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FDA Recalls

January 2009 - June 2009

• Recalls as of June 24, 2009
• Recalls as of June 17, 2009
• Recalls as of June 10, 2009
• Recalls as of June 3, 2009
• Recalls as of May 27, 2009
• Recalls as of May 20, 2009
• Recalls as of May 13, 2009
• Recalls as of May 6, 2009
• Recalls as of April 29, 2009
• Recalls as of April 22, 2009
• Recalls as of April 15, 2009
• Recalls as of April 8, 2009
• Recalls as of April 1, 2009
• Recalls as of March 25, 2009
• Recalls as of March 18, 2009
• Recalls as of March 11, 2009
• Recalls as of March 4, 2009
• Recalls as of February 25, 2009
• Recalls as of February 18, 2009
• Recalls as of February 11, 2009
• Recalls as of February 4, 2009
• Recalls as of January 28, 2009:
• Recalls as of January 21, 2009:
• Recalls as of January 14, 2009:
• Recalls as of January 7, 2009:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 24, 2009:

CLASS II

PRODUCT: Remstar Pro M-Series CPAP and Heated Humidifier System. Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109. Recall # Z-1260-2009

MANUFACTURER: Respironics, Monroeville, PA, by letter dated February 5, 2009. Firm initiated recall is ongoing.

REASON: Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier PCA.

PRODUCT: Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL. Used to obtain endometrial samples for both cytology and histology. Intended for one-time use. Recall # Z-1416-2009

MANUFACTURER: Cook OB/Gyn, Inc, Spencer, IN, by letter dated April 2, 2009. Firm initiated recall is ongoing.

REASON: There is an ink on the brush which has not been tested for use with the Tao Brush.

PRODUCT:
1) STERRAD 50 Sterilization System Product Code 10050 The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Recall # Z-1419-2009;
2) STERRAD NX Sterilization System Product Code 10033 The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Recall # Z-1420-2009

MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by letters dated March 9, 2009. Firm initiated recall is ongoing.

REASON: ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs.

RODUCT:
1) Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 7721165 Upper Body radiation shield, fixed. Used with the following systems 1) Artis Zee floor Model number 10094135; 2) Artis Zee ceiling Model number 10094137; 3) Artis Zee biplane Model number 10094141; 4) Artis Zee floor MN Model number 10094142; 5) Multistar D Model number 3772501; 6) Axiom Iconos R200 Model number 5902775; 7) Axiom Artis FC Model number 5904433; 8) Axiom Artis MP Model number 5904466; 9) Axiom Artis BC Model number 5904649; 10) Axiom Artis BA Model number 5904656; 11) Axiom Artis TA Model number 7007755; 12) Axiom Artis dTA Model number 7008605;
13) Axiom Artis dFC Model number 7412807; 14) Axiom Artis dTC Model number 7413078; 15) Axiom Artis dMP Model number 7555365; 16) Axiom Artis dFA Model number 7555373;17) Axiom Artis dFC Model number 7727717; 18) Axiom Artis TC Model number 7728350; 19) Axiom Artis dBC Model number 7728392; 20) Somatom Definition AS Model number 8098027. Recall # Z-1437-2009;
2) Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 4787714 Upper Body radiation shield, Artis floor. Used with the following systems 1) Artis Zee floor Model number 10094135; 2) Artis Zee ceiling Model number 10094137; 3) Artis Zee biplane Model number 10094141; 4) Artis Zee floor MN Model number 10094142; 5) Multistar D Model number 3772501; 6) Axiom Iconos R200 Model number 5902775; 7) Axiom Artis FC Model number 5904433; 8) Axiom Artis MP Model number 5904466; 9) Axiom Artis BC Model number 5904649; 10) Axiom Artis BA Model number 5904656; 11) Axiom Artis TA Model number 7007755; 12) Axiom Artis dTA Model number 7008605; 13) Axiom Artis dFC Model number 7412807; 14) Axiom Artis dTC Model number 7413078; 15) Axiom Artis dMP Model number 7555365; 16) Axiom Artis dFA Model number 7555373; 17) Axiom Artis dFC Model number 7727717; 18) Axiom Artis TC Model number 7728350; 19) Axiom Artis dBC Model number 7728392; 20) Somatom Definition AS Model number 8098027. Recall # Z-1438-2009;
3) Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 7559375 Upper Body radiation shield, Artis T. Used with the following systems: 1) Artis Zee floor Model number 10094135; 2) Artis Zee ceiling Model number 10094137; 3) Artis Zee biplane Model number 10094141; 4) Artis Zee floor MN Model number 10094142; 5) Multistar D Model number 3772501; 6) Axiom Iconos R200 Model number 5902775; 7) Axiom Artis FC Model number 5904433; 8) Axiom Artis MP Model number 5904466; 9) Axiom Artis BC Model number 5904649; 10) Axiom Artis BA Model number 5904656; 11) Axiom Artis TA Model number 7007755; 12) Axiom Artis dTA Model number 7008605; 13) Axiom Artis dFC Model number 7412807; 14) Axiom Artis dTC Model number 7413078; 15) Axiom Artis dMP Model number 7555365; 16) Axiom Artis dFA Model number 7555373; 17) Axiom Artis dFC Model number 7727717; 18) Axiom Artis TC Model number 7728350; 19) Axiom Artis dBC Model number 7728392; 20) Somatom Definition AS Model number 8098027. Recall # Z-1439-2009;
4) Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 10281150 Surgery
lamp, 230V. Used with the following systems 1) Artis Zee floor Model number 10094135; 2) Artis Zee ceiling Model number 10094137; 3) Artis Zee biplane Model number 10094141; 4) Artis Zee floor MN Model number 10094142; 5) Multistar D Model number 3772501; 6) Axiom Iconos R200 Model number 5902775; 7) Axiom Artis FC Model number 5904433; 8) Axiom Artis MP Model number 5904466; 9) Axiom Artis BC Model number 5904649; 10) Axiom Artis BA Model number 5904656; 11) Axiom Artis TA Model number 7007755; 12) Axiom Artis dTA Model number 7008605; 13) Axiom Artis dFC Model number 7412807; 14) Axiom Artis dTC Model number 7413078; 15) Axiom Artis dMP Model number 7555365; 16) Axiom Artis dFA Model number 7555373; 17) Axiom Artis dFC Model number 7727717; 18) Axiom Artis TC Model number 7728350; 19) Axiom Artis dBC Model number 7728392; 20) Somatom Definition AS Model number 8098027. Recall # Z-1440-2009;
5) Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 10281151 Surgery lamp, 115V. Used with the following systems 1) Artis Zee floor Model number 10094135; 2) Artis Zee ceiling Model number 10094137; 3) Artis Zee biplane Model number 10094141; 4) Artis Zee floor MN Model number 10094142; 5) Multistar D Model number 3772501; 6) Axiom Iconos R200 Model number 5902775; 7) Axiom Artis FC Model number 5904433; 8) Axiom Artis MP Model number 5904466; 9) Axiom Artis BC Model number 5904649; 10) Axiom Artis BA Model number 5904656; 11) Axiom Artis TA Model number 7007755; 12) Axiom Artis dTA Model number 7008605; 13) Axiom Artis dFC Model number 7412807; 14) Axiom Artis dTC Model number 7413078; 15) Axiom Artis dMP Model number 7555365; 16) Axiom Artis dFA Model number 7555373; 17) Axiom Artis dFC Model number 7727717; 18) Axiom Artis TC Model number 7728350; 19) Axiom Artis dBC Model number 7728392; 20) Somatom Definition AS Model number 8098027. Recall # Z-1441-2009;
6) Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 10281152 3-bulb surgery lamp, 230V. Used with the following systems: 1) Artis Zee floor Model number 10094135; 2) Artis Zee ceiling Model number 10094137; 3) Artis Zee biplane Model number 10094141; 4) Artis Zee floor MN Model number 10094142; 5) Multistar D Model number 3772501; 6) Axiom Iconos R200 Model number 5902775; 7) Axiom Artis FC Model number 5904433; 8) Axiom Artis MP Model number 5904466; 9) Axiom Artis BC Model number 5904649; 10) Axiom Artis BA Model number 5904656; 11) Axiom Artis TA Model number 7007755; 12) Axiom Artis dTA Model number 7008605; 13) Axiom Artis dFC Model number 7412807; 14) Axiom Artis dTC Model number 7413078; 15) Axiom Artis dMP Model number 7555365; 16) Axiom Artis dFA Model number 7555373; 17) Axiom Artis dFC Model number 7727717; 18) Axiom Artis TC Model number 7728350; 19) Axiom Artis dBC Model number 7728392; 20) Somatom Definition AS Model number 8098027. Recall # Z-1442-2009;
7) Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 10281153 3-bulb surgery lamp, 115V. Used with the following systems 1) Artis Zee floor Model number 10094135; 2) Artis Zee ceiling Model number 10094137; 3) Artis Zee biplane Model number 10094141; 4) Artis Zee floor MN Model number 10094142; 5) Multistar D Model number 3772501; 6) Axiom Iconos R200 Model number 5902775; 7) Axiom Artis FC Model number 5904433; 8) Axiom Artis MP Model number 5904466; 9) Axiom Artis BC Model number 5904649; 10) Axiom Artis BA Model number 5904656; 11) Axiom Artis TA
Model number 7007755; 12) Axiom Artis dTA Model number 7008605; 13) Axiom Artis dFC Model number 7412807; 14) Axiom Artis dTC Model number 7413078; 15) Axiom Artis dMP Model number 7555365; 16) Axiom Artis dFA Model number 7555373; 17) Axiom Artis dFC Model number 7727717; 18) Axiom Artis TC Model number 7728350; 19) Axiom Artis dBC Model number 7728392; 20) Somatom Definition AS Model number 8098027. Recall # Z-1443-2009

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by visit beginning May 1, 2009. Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.

REASON: Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.

PRODUCT:
1) Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB55 - size 5-1/2; Made in Thailand. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound. Recall # Z-1445-2009;
2) Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB60 - size 6;
Made in Thailand. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound. Recall # Z-1446-2009;
3) Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB65 - size 6-1/2; Made in Thailand. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound. Recall # Z-1447-2009;
4) Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB70 - size 7; Made in Thailand. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound. Recall # Z-1448-2009;
5) Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB75 - size 7-1/2; Made in Thailand. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound. Recall # Z-1449-2009;
6) Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB80 - size 8; Catalog #SOP69CAFCD and #SOP69CAFCE; Made in Thailand. One pair of size 8 gloves was included as a component of the following Presource Custom Sterile Surgery Packs: Catalog #SOP69CAFCD - Clovis Dr Simonian Arthroscopy Pack; Catalog #SOP69CAFCE - Clovis Dr Simonian Arthroscopy Pack. The affected glove pouch was located outside of the sterile pack. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound. Recall # Z-1450-2009;
7) Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB85 - size 8-1/2; Made in Thailand. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound. Recall # Z-1451-2009;
8) Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per case; REF2D73PB90 - size 9; Made in Thailand. To be worn as an under glove by operating room personnel to protect a surgical wound from contamination in environments within the hospital and other healthcare facilities. The gloves are appropriate for using during invasive as well as non-invasive medical procedures requiring sterility. The Esteem Blue with Neu Thera surgeons glove is worn as an under glove, in conjunction with a primary surgical glove where the primary surgical glove comes into direct contact with the surgical wound. Recall # Z-1452-2009

MANUFACTURER: Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letters dated April 24, 2009. Manufacturer: Cardinal Health 222, Rayong, Thailand. Firm initiated recall is ongoing.

REASON: Increase in the number of customer complaints due to cuff tears.

PRODUCT:
1) Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120. Recall # Z-1453-2009;
2) Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBL06040. Recall # Z-1454-2009;
3) Bard E LUMINEXX, Biliary Stent Size: 6mm x 80mm, Product Number: ZBL06080. Recall # Z-1455-2009;
4) Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBL12040. Recall # Z-1456-2009;
5) Bard E LUMINEXX Biliary Stent, Size: 14mm x 60mm, Product Number: ZBL14060. Recall # Z-1457-2009;
6) Bard E LUMINEXX Biliary Stent,Size: 6mm x 20mm, Product Number: ZBM06020. Bard E LUMINEXX Biliary Stent, Size: 14mm x 60mm, Product Number: ZBL14060. Recall # Z-1458-2009;
7) Bard E LUMINEXX Biliary Stent, Size: 6mm x 30mm, Product Number: ZBM06030. Bard E LUMINEXX Biliary Stent, Size: 14mm x 60mm, Product Number: ZBL14060. Recall # Z-1459-2009;
8) Bard E LUMINEXX Biliary Stent, Size: 6mm x 40mm, Product Number: ZBM06040. Recall # Z-1460-2009;
9) Bard E LUMINEXX Biliary Stent, Size: 6mm x 60mm, Product Number: ZBM06060. Recall # Z-1461-2009;
10) Bard E LUMINEXX Biliary Stent, Size: 6mm x 80mm, Product Number: ZBM06080. Recall # Z-1462-2009;
11) Bard E LUMINEXX Biliary Stent, Size: 12mm x 40mm, Product Number: ZBM12040. Recall # Z-1463-2009;
12) Bard E LUMINEXX Biliary Stent, Size: 12mm x 60mm, Product Number: ZBM12060. Recall # Z-1464-2009;
13) Bard E LUMINEXX Biliary Stent, Size: 12mm x 80mm Product Number: ZBM12080. Recall # Z-1465-2009;
14) Bard E LUMINEXX Biliary Stent, Size: 14mm x 30mm, Product Number: ZBM14030. Recall # Z-1466-2009;
15) Bard E LUMINEXX Biliary Stent, Size: 14mm x 40mm, Product Number: ZBM14040. Recall # Z-1467-2009;
16) Bard E LUMINEXX Biliary Stent, Size 14mm x 60mm, Product Number: ZBM14060. Recall # Z-1468-2009;
17) Bard E LUMINEXX Biliary Stent, Size: 14mm x 80mm, Product Number: ZBM14080. Recall # Z-1469-2009

MANUFACTURER: Recalling Firm: Bard Peripheral Vascular, Inc, Tempe, AZ, by letter dated December 22, 2008. Manufacturer: Angiomed GmbH & Co. Medizintechnik KG, Karlsruhe, Germany. Firm initiated recall is ongoing.

REASON: This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use".

PRODUCT:
Boston Scientific Wiseguide Guide Catheter, Sterilized. Wiseguide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. Model Numbers: 8F WG FR3.5, 8F WG FR4, 8F WG FR5, 8F WG FR6, 8F WG FL3, 8F WG FL3.5, 8F WG FL4, 8F WG FL4.5, 8F WG FL5, 8F WG FL6, 8F WG AL1.5 ST, 8F WG AL2 ST, 8F WG AL.75 ST, 8F WG AL1 ST SH, 8F WG AL2 ST SH, 8F WG AL.75 ST SH, 8F WG RC3.5 SC SH, 8F WG IM 110cm, 8F WG AL.75 SH, 8F WG AL4 SH, 8F WG RCB SH, 8F WG IM SH, 8F WG FL3.5 ST SH, 8F WG FL4 ST SH, 8F WG FL4.5 ST SH, 8F WG FL5 ST SH, 8F WG MP1 SH, 8F WG MP HS SH, 8F WG FL4P, 8F WG AR1, 8F WG AR2, 8F WG AL1, 8F WG AL2, 8F WG AL3, 8F WG AL.75, 8F WG AL4, 8F WG VR2, 8F WG RCB, 8F WG VL4 HT, 8F WG VR2 SH, 8F WG LCB, 8F WG VL3 HT SH, 8F WG IM, 8F WG FCL3.5 SH, 8F WG FCL4 SH, 8F WG FCL3.5, 8F WG FCL4, 8F WG FCR4 SH, 8F WG FCR3.5, 8F WG FCR4, 8F WG FL3.5 ST, 8F WG FL4 ST, 8F WG Q3.5, 8F WG Q4, 8F WG Q4.5, 8F WG Q3.5 SH, 8F WG Q4 SH, 8F WG Q4.5 SH, 8F WG FL4.5 ST, 8F WG FL5 ST, 8F WG FR4 90cm, 8F WG MP1, 8F WG RCB 90cm, 8F WG MP2, 8F WG MP HS, 8F WG FR3, 8F WG FR3 SH, 8F WG IM 90cm, 8F WG IM 90cm SH, 8F WG RC4 SC, 8F WG RC4 SC SH, 8F WG RC3.5 SC, 8F WG FR3.5 SH, 8F WG FR4 SH, 8F WG FR5 SH, 8F WG ART3, 8F WG ART3 SH, 8F WG ART3.5, 8F WG ART3.5 SH, 8F WG ART4, 8F WG FR6 SH, 8F WG ART4 SH, 8F WG FL3 SH, 8F WG FR4.5, 8F WG FR4.5 SH, 8F WG FL3.5 SH, 8F WG FL4 SH, 8F WG FL4.5 SH, 8F WG FL5 SH, 8F WG FL6 SH, 8F WG FL4A SH, 8F WG CLS3, 8F WG CLS3.5, 8F WG CLS4, 8F WG CLS4.5, 8F WG CLS3 SH, 8F WG CLS3.5 SH, 8F WG CLS4 SH, 8F WG CLS4.5 SH, 8F WG IMC

90cm, 8F WG AR1 SH, 8F WG AR2 SH, 8F WG AL1 SH, 8F WG AL2 SH, 8F WG AL3 SH, 8F WG VL3, 8F WG VL3.5, 8F WG VL4, 8F WG VL4.5, 8F WG VL3 SH, 8F WG VL3.5 SH, 8F WG VL4 SH, 8F WG VL4.5 SH, 8F WG VL5 SH, 8F WG VL6 SH, 8F WG AL1.5, 8F WG AL1.5 SH, 8F WG FR3.5 ST, 8F WG FR4 ST, 8F WG FR3.5 ST SH, 8F WG FR4 ST SH, 7F WISEGUIDE FR3.5, 7F WISEGUIDE FR4, 7F WISEGUIDE FR5, 7F WISEGUIDE FR6, 7F WISEGUIDE FL3, 7F WISEGUIDE FL3.5, 7F WISEGUIDE FL4, 7F WISEGUIDE FL4.5, 7F WISEGUIDE FL5, 7F WISEGUIDE FL6, 7F WISEGUIDE AL1 ST, 7F WISEGUIDE AL.75 ST, 7F WISEGUIDE AL1 ST SH, 7F WISEGUIDE AL.75 ST SH, 7F WISEGUIDE RC3.5 SC SH, 7F WISEGUIDE IM 85cm, 7F WISEGUIDE IM 110cm, 7F WISEGUIDE AL.75 SH, 7F WISEGUIDE AL4 SH, 7F WISEGUIDE RCB SH, 7F WISEGUIDE LCB SH, 7F WISEGUIDE IM SH, 7F WISEGUIDE MP EL G SH, 7F WISEGUIDE FL3.5 ST SH, 7F WISEGUIDE FL4 ST SH, 7F WISEGUIDE FL4.5 ST SH, 7F WISEGUIDE FL5 ST SH, 7F WISEGUIDE MP1 SH, 7F WISEGUIDE MP2 SH, 7F WISEGUIDE MP HS SH, 7F WISEGUIDE AR1, 7F WISEGUIDE AR2, 7F WISEGUIDE AL1, 7F WISEGUIDE AL2, 7F WISEGUIDE AL3, 7F WISEGUIDE AL.75, 7F WISEGUIDE AL4, 7F WISEGUIDE VL2.5, 7F WISEGUIDE RCB, 7F WISEGUIDE VL3 HT, 7F WISEGUIDE LCB, 7F WISEGUIDE IM, 7F WISEGUIDE FCL3.5 SH, 7F WISEGUIDE FCL4 SH, 7F WISEGUIDE MP EL G, 7F WISEGUIDE FCL4.5 SH, 7F WISEGUIDE FCL3.5, 7F WISEGUIDE FCL4, 7F WISEGUIDE FCL5, 7F WISEGUIDE FCR5 SH, 7F WISEGUIDE FL3.5 ST, 7F WISEGUIDE FCR4, 7F WISEGUIDE FCR5, 7F WISEGUIDE FL4 ST, 7F WISEGUIDE Q3.5, 7F WISEGUIDE Q4, 7F WISEGUIDE Q4.5, 7F WISEGUIDE Q5, 7F WISEGUIDE Q3.5 SH, 7F WISEGUIDE Q4 SH, 7F WISEGUIDE Q4.5 SH, 7F WISEGUIDE FL4.5 ST, 7F WISEGUIDE FL5 ST, 7F WISEGUIDE MP1, 7F WISEGUIDE MP2, 7F WISEGUIDE MP HS, 7F WISEGUIDE FR3, 7F WISEGUIDE FR3 SH, 7F WISEGUIDE IM 90cm, 7F WISEGUIDE IM 90cm SH, 7F WISEGUIDE RC4 SC, 7F WISEGUIDE RC4 SC SH, 7F WISEGUIDE RC3.5 SC, 7F WISEGUIDE FR3.5 SH, 7F WISEGUIDE FR4 SH, 7F WISEGUIDE FR5 SH, 7F WISEGUIDE ART3, 7F WISEGUIDE ART3 SH, 7F WISEGUIDE ART3.5, 7F WISEGUIDE ART3.5 SH, 7F WISEGUIDE FR6 SH, 7F WISEGUIDE ART4, 7F WISEGUIDE ART4 SH, 7F WISEGUIDE ART4.5, 7F WISEGUIDE ART4.5 SH, WISEGUIDE FL3 SH, 7F WISEGUIDE FR4.5, 7F WISEGUIDE FR4.5 SH, 7F WISEGUIDE FL3.5 SH, 7F WISEGUIDE FL4 SH, 7F WISEGUIDE FL5 SH, 7F WISEGUIDE FL6 SH, 7F WISEGUIDE CLS3, 7F WISEGUIDE CLS3.5, 7F WISEGUIDE CLS4, 7F WISEGUIDE CLS4.5, 7F WISEGUIDE CLS3 SH, 7F WISEGUIDE CLS3.5 SH, 7F WISEGUIDE IMC 90cm, 7F WISEGUIDE AR1 SH, 7F WISEGUIDE AR2 SH, 7F WISEGUIDE AL1 SH, 7F WISEGUIDE AL2 SH, 7F WISEGUIDE AL3 SH, 7F WISEGUIDE VL3, 7F WISEGUIDE VL3.5, 7F WISEGUIDE VL4, 7F WISEGUIDE VL4.5, 7F WISEGUIDE VL5, 7F WISEGUIDE VL6, 7F WISEGUIDE VL3 SH, 7F WISEGUIDE VL3.5 SH, 7F WISEGUIDE VL4 SH, 7F WISEGUIDE AL1.5, 7F WISEGUIDE AL1.5 SH, 7F WISEGUIDE FR3.5 ST, 7F WISEGUIDE FR4 ST, 7F WISEGUIDE FR4 ST SH, 6F WISEGUIDE FR3.5, 6F WISEGUIDE FR4, 6F WISEGUIDE FR5, 6F WISEGUIDE FR6, 6F WISEGUIDE FL3, 6F WISEGUIDE FL3.5, 6F WISEGUIDE FL4, 6F WISEGUIDE FL4.5, 6F WISEGUIDE FL5, 6F WISEGUIDE FL6, 6F WISEGUIDE IM 85cm, 6F WISEGUIDE RCB SH, 6F WISEGUIDE LCB SH, 6F WISEGUIDE IM SH, 6F WISEGUIDE MP1 SH, 6F WISEGUIDE MP HS SH, 6F WISEGUIDE AR1, 6F WISEGUIDE AR2, 6F WISEGUIDE AL1, 6F WISEGUIDE AL2, 6F WISEGUIDE AL3, 6F WISEGUIDE AL.75, 6F WISEGUIDE AL4, 6F WISEGUIDE VR1, 6F WISEGUIDE VR2, 6F WISEGUIDE RCB, 6F WISEGUIDE VL3.5 HT, 6F WISEGUIDE VL4 HT, 6F WISEGUIDE LCB 6F WISEGUIDE IM, 6F WISEGUIDE FCL3.5, 6F WISEGUIDE FCL4, 6F WISEGUIDE FCL4.5, 6F WISEGUIDE FCR3.5, 6F WISEGUIDE FL4 ST, 6F WISEGUIDE Q3.5, 6F

WISEGUIDE Q4, 6F WISEGUIDE Q4.5, 6F WISEGUIDE Q5, 6F WISEGUIDE Q3.5 SH, 6F WISEGUIDE Q4 SH, 6F WISEGUIDE FL4.5 ST, 6F WISEGUIDE FL5 ST, 6F WISEGUIDE MP1, 6F WISEGUIDE MP2, 6F WISEGUIDE MP HS, 6F WISEGUIDE FR3, 6F WISEGUIDE IM 90cm, 6F WISEGUIDE FR3.5 SH, 6F WISEGUIDE Radial ST, 6F WISEGUIDE Radial, 6F WISEGUIDE FR4 SH, 6F WISEGUIDE ART3, 6F WISEGUIDE ART3 SH, 6F WISEGUIDE ART3.5, 6F WISEGUIDE ART3.5 SH, 6F WISEGUIDE ART4, 6F WISEGUIDE ART4 SH, 6F WISEGUIDE ART4.5, 6F WISEGUIDE FL3.5 SH, 6F WISEGUIDE FL4 SH, 6F WISEGUIDE ML4, 6F WISEGUIDE Radial FX, 6F WISEGUIDE CLS3, 6F WISEGUIDE CLS3.5, 6F WISEGUIDE CLS4, 6F WISEGUIDE CLS4.5, 6F WISEGUIDE CLS3.5 SH, 6F WISEGUIDE KIMNY, 6F WISEGUIDE KIMNY FX, 6F WISEGUIDE KIMNY SH, 6F WISEGUIDE IMC 90cm, 6F WISEGUIDE AR1 SH, 6F WISEGUIDE AR2 SH, 6F WISEGUIDE AL1 SH, 6F WISEGUIDE AL2 SH, 6F WISEGUIDE VL3, 6F WISEGUIDE VL3.5, 6F WISEGUIDE VL4, 6F WISEGUIDE VL4.5, 6F WISEGUIDE VL5, 6F WISEGUIDE VL6, 6F WISEGUIDE VL3.5 SH, 6F WISEGUIDE VL4 SH, 6F WISEGUIDE AL1.5, 6F WISEGUIDE FR3.5 ST and 6F WISEGUIDE FR4 ST. Recall # Z-1470-2009

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Maple Grove, MN, by letter dated March 11, 2009. Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C Mex, Mexico. Firm initiated recall is ongoing.

REASON: Boston Scientific has initiated a recall of the Wiseguide Guide Catheter. They have received reports of difficulties in connecting the product hubs with the Y-Adaptors and toughy borst connectors. If there is difficulty making such connection, there is a potential for prolongation or delay of the procedure in order to exchange the catheter or connector.

PRODUCT:
1) ReSolve Halo - Open Back Halo Ring, Model Number: 505300D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury. Recall # Z-1507-2009;
2) ReSolve Halo - Open Back Halo Ring, Model Number: 505400D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury. Recall # Z-1508-2009;
3) ReSolve Halo - Open Back Halo Ring, Model Number: 510400D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury. Recall # Recall # Z-1509-2009

MANUFACTURER: Ossur Engineering, Inc, Albion, MI, by telephone beginning on November 10, 2008 and by letter beginning on November 12, 2008. Firm initiated recall is complete.

REASON: Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring

CLASS III

PRODUCT
1) i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific,
Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.
Z-1540-2009;
2) i-STAT G3+ Cartridge; pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for calculated HCO3 and PO2 for calculated oxygen saturated/sO2. Catalog Number 220100. The iSTAT G3+ Cartridge is intended to be used to quantitatively measure oxygen, carbon dioxide, and pH. Recall # Z-1541-2009

MANUFACTURER: Abbott Point of Care, Inc, East Windsor, NJ, by letters on February 23, 2009 and letters dated May 2009. Firm initiated recall is ongoing.

REASON: Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 17, 2009:

CLASS II

PRODUCT: TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection. Model number is MG412110. The device is a single use device. Recall # Z-1244-2009

MANUFACTURER: Migada Inc., Kiryat, Shmona, Israel, by a Field Safety Notice, dated December 8, 2008. Firm initiated recall is ongoing.

REASON: Syringe adaptor is disintegrating when attached to the end of the syringe.

PRODUCT: Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide. Recall # Z-1348-2009

MANUFACTURER: Recalling Firm: Synthes Spine, West Chester, PA, by e-mail on February 10, 2009 and by letter on March 26, 2009. Manufacturer: Synthes Gmbh, Switzerland. Firm initiated recall is ongoing.

REASON: Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening.

PRODUCT:
a) Prelude Short Sheath Introducer, Carolina Kidney and Endocrine - Declot tray, K12T-02693. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1402-2009;
b) Prelude Short Sheath Introducer, McAlester Regional Hospital - Fistulagram Pack, K12T-02894C. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1403-2009;
c) 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.: PSS-5F-4-018MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1404-2009;
d) 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide Wire, REF No.: PSS-5F-4-038MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1405-2009;
e) 5F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-5F-4MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1406-2009;
f) 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.: PSS-6F-4-018MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1407-2009;
g) 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide Wire, REF No.: PSS-6F-4-038MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while
maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1408-2009;
h) 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No: PSS-6F-4MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1409-2009;
i) 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.: PSS-7F-4-018MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1410-2009;
j) 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide Wire; REF No.: PSS-7F-4-038MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1411-2009;
k) 7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-7F-4MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1412-2009;
l) 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 7CM Advance Needle; and 0.018" X 40CM NT/PT Guide Wire; REF No.: PSS-8F-4-018MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1413-2009;
m) 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM, REF No.: PSS-8F-4-038MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1414-2009;
n) 8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-8F-4MT, Sterile EO. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. This device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. Recall # Z-1415-2009

MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by letter on April 14, 2009. Firm initiated recall is ongoing.

REASON: External tubing may separate during use, allowing blood loss.

PRODUCT:
a) IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin-Lock Connector, Catalog # 352049. For use with Secondary Container. Recall # Z-1427-2009;
b) Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520. For use with the Horizon NXT Pump, and OutLook Safety Infusion System. Recall # Z-1428-2009;
c) Primary IV Set with Universal Spike, Backcheck Valve, 3 Ultrasite Injection Sites and Spin-Lock Connector, Catalog # 375100. For use with Secondary Container. Recall # Z-1429-2009;
d) Ultrasite IV Administration Set with Universal Spike, three Backcheck Valves, three Ultrasite Injection Sites and Spin-Lock Connector, Catalog #470007. For use with Secondary Container. Recall # Z-1430-2009;
e) Outlook Safety Infusion System IV Set with Universal Spike, Backcheck Valve, Ultrasite Injection Site and Spin-Lock Connector, Catalog #470046. For use with the Horizon NXT Pump, and OutLook Safety Infusion System. Recall # Z-1431-2009;
f) Anesthesia IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites, Injection Site, Ultraport High-Flow 4-Way Stopcock with Single Valve Port and Spin-Lock Connector, Catalog # 490060. For use with Secondary Container. Recall # Z-1432-2009;
g) Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites and Spin-Lock Connector, Catalog # US3485. For use with Secondary Container. Recall # Z-1433-2009;
h) ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Injection Sites and Spin-Lock Connector, Catalog # V1443. For use with Secondary Container. Recall #
Z-1434-2009

MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter on March 27, 2009. Manufacturer: B. Braun of Dominican Republic, Parque Las Americas, Dominican Republic. Firm initiated recall is ongoing.

REASON: Device defect is occlusion/no flow.

PRODUCT: WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System. The WalkAide is a battery operated, single channel electrical stimulator that is used to improve walking ability by stimulating a foot lift at the appropriate time during the step cycle. Recall # Z-1435-2009

MANUFACTURER: Recalling Firm: Innovative Neurotronics, Inc., Austin, TX, by e-mail on August 6, 2008. Manufacturer: Kimball Electronics Tampa Inc., Tampa FL. Firm initiated recall is ongoing.

REASON: Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use.

PRODUCT: CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage. Recall # Z-1436-2009

MANUFACTURER: Philips Healthcare, Inc., Andover, MA, by letter on May 6, 2009. Firm initiated recall is ongoing.

REASON: A software defect under certain circumstances could lead to the unintended administration of a duplicate dose of a scheduled medication within a single 24 hour period.

CLASS III

PRODUCT: TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion. Recall # Z-1325-2009

MANUFACTURER: MDS Canada Inc. DBA MDS Nordion, Ottawa Ontario, Canada, by a User Bulletin dated February 23, 2009. Firm initiated recall is complete.

REASON: Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set were not included with the distribution of the device.

PRODUCT: EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; indicated for use during clinical electrophysiology procedures. Recall # Z-1422-2009

MANUFACTURER: St. Jude Medical, West Berlin, NJ, by letters on March 23, 2009. Firm initiated recall is ongoing.

REASON: Non-compliance with IEC Standard 60601-1 Clause 57.6 relative to fusing of AC input line. The neutral line is not fused. The hot line in fused. Clause 57.6 calls for both lines to be fused.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 10, 2009:

CLASS II

PRODUCT: Terumo Advanced Perfusion System 1 Central Control Monitor; Catalog number 802100. The Central Control Monitor (CCM) provides a centralized display of system information and on-screen control of all system devices. The CCM combines an embedded computer, a touchscreen, and a graphical user interface. Recall # Z-1224-2009

MANUFACTURER: Terumo Cardiovascular Systems Corp. Ann Arbor, MI, by letter dated January 12, 2009. Firm initiated recall is ongoing.

REASON: The monitor may exhibit start-up failure, video/display issues, calibration issues, and partial or complete loss of functionality during use.

PRODUCT: Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, individually packaged catheter introducer. Recall # Z-1264-2009

MANUFACTURER: Spectranetics Corporation, Colorado Springs, CO, by letter on March 17, 2009. Firm initiated recall is complete.

REASON: Catheter outer jacket may split during use.

PRODUCT: Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system. Recall # Z-1318-2009

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc. Malvern, PA, by letter dated January 22, 2009. Manufacturer: Siemens Ag Healthcare Sector, Erlangen, Germany. Firm initiated recall is complete.

REASON: Table may unintentionally lift during procedure.

PRODUCT:
a) Stryker Gamma3 Plus Obese Targeting System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails. Catalog number LG3P-OT, this is the surgical technique brochure. Recall # Z-1349-2009;
b) Stryker Gamma3S Trochanteric Nail 170, Operative Technique for Hip Fracture System. Catalog number LG3S-OT. Recall # Z-1350-2009;
c) Stryker Gamma3, the Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails. Catalog number LG3P-OT, this is the surgical technique brochure. Recall # Z-1351-2009;

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letters on March 2, 2009. Manufacturer: Stryker Trauma GmbH, Schonkirchen, Germany


REASON: Operative Technique: further clarification and guidance is needed to help reduce the potential for distal mis-drilling of the short Gamma3 Trochanteric Nails.

PRODUCT: a) Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. Recall # Z-1352-2009; b) Biomet Dual Offset Broach Handle, Clamping Style, Right, REF 31-555404. Recall # Z-1353-2009

MANUFACTURER: Biomet, Inc. Warsaw, IN, by letter dated March 31, 2009. Firm initiated recall is ongoing.

REASON: The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach.

PRODUCT: HeartStart MRx Defibrillator/Monitor, M3535A/M3536A Is used for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. Recall # Z-1390-2009

MANUFACTURER: Philips Healthcare Inc., Andover, MA, by letter dated March 2009. Firm initiated recall is ongoing.

REASON: Spontaneous turn-on which could deplete the battery, rendering the device unusable until power is restored. There is also the possibility of a failure mode in which the device fails to respond to user initiated turn-on, rendering it unusable for monitoring and therapy.

PRODUCT: Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001. Recall # Z-1415-2009

MANUFACTURER: Recalling Firm: Disetronic Medical Systems, Inc. Fishers, IN, by press release on April 30, 2009 and by letters dated May 4, 2009.
Manufacturer: Disetronic Medical Systems AG, Burgdorf, Switzerland. Firm initiated recall is ongoing.

REASON: The “up” and “down” buttons, which are used for changing the program in the menu or to administer additional insulin through a bolus delivery, may experience intermittent failure or completely cease to operate.

PRODUCT: CHIBA Needle Marked, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each. The device is used as a General Purpose Aspiration and Injection Needle. Recall # Z-1417-2009

MANUFACTURER: Remington Medical, Inc. Alpharetta, GA, by telephone on April 6, 2009 and by letter dated April 13, 2009. Firm initiated recall is complete.

REASON: Incorrect needle (Franseen Needle, FNM-1806) was packaged as a Chiba Needle Marked.

PRODUCT: Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part of the VERTIER Surgical Tables or individually by Stryker 100 Communications. The Vertier surgical table is intended for use in general surgery or diagnostic examinations to position a patient. The Vertier Surgical Table is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. The headrest is included with each table. Recall # Z-1418-2009

MANUFACTURER: Recalling Firm: Stryker Communications Corporation, Flower Mound, TX, by letter dated May 11, 2009. Manufacturer: Merivaara Corporation, Lahti, Finland. Firm initiated recall is ongoing.

REASON: Potential for health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the VERTIER Surgical Table.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 3, 2009:

CLASS II

PRODUCT: GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring. Recall # Z-1227-2009

MANUFACTURER: Recalling Firm: GE Healthcare, Wauwatosa, WI, by letter dated February 12, 2009. Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.

REASON: Intermittent or continuous loss of patient monitoring.

PRODUCT: MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media. Recall # Z-1228-2009

MANUFACTURER: Medrad, Inc., Indianola, PA, by letter on January 29, 2009. Firm initiated recall is complete.

REASON: Possible compromised sterility due to holes in styrene tray.

PRODUCT:
a) Synthes InSitu Bender Cutter Kit Wide Sterile Catalog number 530.521S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. Recall # Z-1248-2009;
b) Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. Recall # Z-1249-2009

MANUFACTURER: Recalling Firm: Synthes Spine, West Chester, PA, by telephone on December 19, 2008 and by letter on December 22, 2008. Manufacturer: Synthes USA, Monument, CO. Firm initiated recall is ongoing.

REASON: The bender is heating prior to activation of the power button, requiring disassembly to stop heating.

PRODUCT: Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. Recall # Z-1265-2009

MANUFACTURER: Imaging Sciences International, LLC, Hatfield, PA, by letter dated January 7, 2009. Firm initiated recall is ongoing.

REASON: Faulty calibration

PRODUCT:
1) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087301, .035/150cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1267-2009;

2) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087302, .035/180cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1268-2009;

3) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087303, .035/300 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1269-2009;

4) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087304, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1270-2009;

5) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087305, .035/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1271-2009;

6) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087306, .035/300 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1272-2009;

7) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087308, .035/180 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1273-2009;

8) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087309, .035/300 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1274-2009;

9) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087311, .035/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1275-2009;

10) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087312, .035/300 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1276-2009;

11) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087313, .038/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1277-2009;

12) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087314, .038/180 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1278-2009;

13) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087315, .038/300 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1279-2009;

14) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087316, .038/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1280-2009;

15) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087317, .038/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1281-2009;

16) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087326, .032/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1282-2009;

17) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387301, .035/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1283-2009;

18) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387302, .035/180 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1284-2009;

19) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387303, .035/300 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1285-2009;

20) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387304, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1286-2009;

21) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387305, .035/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1287-2009;

22) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387306, .035/300 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1288-2009;

23) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387307, .035/150 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1289-2009;

24) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387308, .035/180 cm, still/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1290-2009;

25) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387309, .035/300 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1291-2009;

26) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387310, .035/150 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1292-2009;

27) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387311, .035/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1293-2009;

28) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387312, .035/300 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1294-2009;

29) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387313, .038/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1295-2009;

30) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387314, .038/180 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1296-2009;

31) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387316, .038/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1297-2009;

32) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387318, .038/300 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1298-2009;

33) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387319, .038/150 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1299-2009;

34) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387320, .038/180 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1300-2009;

35) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387321, .038/300 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1301-2009;

36) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387322, .038/150 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1302-2009;

37) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387323, .038/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1303-2009;

38) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387325, .032/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1304-2009;

39) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387326, .032/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1305-2009;

40) Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1306-2009;

41) Hydrophilic Guidewire, Catalog Number: VM18352, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1307-2009

MANUFACTURER: Argon Medical Devices, Inc., Athens, TX, by letter dated February 26, 2009. Firm initiated recall is ongoing.

REASON: Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.

PRODUCT: Lactosorb Pectus Stabilizer, model number: 01-3805. LactoSorb Pectus Stabilizer is a surgical implant intended to aid in the treatment of Pectus Excavatum deformities. The LactoSorb Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Pectus Support Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity. Recall # Z-1323-2009

MANUFACTURER: Biomet Microfixation, Inc., Jacksonville, FL, by letter or email on March 20, 2009. Firm initiated recall is ongoing.

REASON: This recall is based on the occurrence of known adverse effects identified in the device instructions for use. Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing. Implantation of foreign materials can result in an inflammatory response or allergic reaction.

PRODUCT:
Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure components together or as a means of bone distraction/compression. Each side of the Square Nut is etched with a number, 1-2-3-4, which can be referenced during distraction/compression. Distraction of bone typically occurs a rate of 1mm/day. The patient may be instructed to turn the nuts 1/4 turn four times per day, accomplishing 0.25mm per 1/4 turn. The etched numbers offer reference points to the surgeon who instructs the patient on distraction technique. Recall # Z-1324-2009

MANUFACTURER: Synthes Spine, West Chester, PA, by letter dated February 6, 2009 and email on February 09, 2009.Manufacturer: Synthes USA, Monument, CO. Firm initiated recall is ongoing. Firm initiated recall is ongoing.

REASON: Numbers are etched incorrectly on the product.

PRODUCT: ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; list 7C15-01. The ARCHITECT Reaction Vessels are disposable containers in which the Chemiluminescent Microparticle Immunoassay (CMIA) reaction takes place for sample analysis. Recall # Z-1392-2009

MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by telephone and letter dated February 26, 2009. Firm initiated recall is ongoing.

REASON: Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test, background read failure), error code 1007 (unable to process test, activated read failure) and incorrect results when using these lots of ARCHITECT Reaction Vessels.

PRODUCT: Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01. Product is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: autoloader that aspirates samples from closed collection tubes, and open tube mode that aspirates samples from open collection tubes. Recall # Z-1398-2009

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letter dated February 12, 2009. Firm initiated recall is ongoing.

REASON: Burn Risk-- when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may reach 100 degrees Celsius (212 degrees Fahrenheit). If the customer touches the motor, burns may occur.

PRODUCT:
a) Immulite 2000 and
b) Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing. Recall # Z-1399-2009

MANUFACTURER:
Siemens Medical Solutions Diagnostics, Flanders, NJ, by letter dated January 2009. Firm initiated recall is ongoing.

REASON: Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.

PRODUCT: Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7. Datascope Patient Monitoring Intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. Recall # Z-1401-2009

MANUFACTURER: Mindray DS USA, Inc., dba Datascope Patient Monitoring, Mahwah NJ, by letters, dated March 27, 2009. Firm initiated recall is ongoing.

REASON: Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.

PRODUCT: a) Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System. Recall # Z-1412-2009;
b) Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #: a) 10240-03, b) 11077-03, c) 11187-02 and d) 13305-01. Recall # Z-1413-2009

MANUFACTURER: Recalling Firm: Alcon Laboratories, Inc., Fort Worth, TX, by letter on April 29, 2009. Manufacturer: Alcon Manufacturing LTD, Sinking Spring PA. Firm initiated recall is ongoing.

REASON: Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.

PRODUCT: Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box, Non-Sterile, For Medical Use, Catalogue Numbers: 55031, 55032, and 55033. Recall # Z-1414-2009

MANUFACTURER: Recalling Firm: Kimberly Clark Corp., Roswell, GA, by letter on/about April 30, 2009. Manufacturer: Shijiazhuang Hongxiang Plastic Products Co., Ltd., Lu Quan City, Hebei, China. Firm initiated recall is ongoing.

REASON: The product may contain defects /holes reducing the product’s effectiveness as a barrier.

CLASS III

PRODUCT:
a) Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C2501, and 305C2901; Sterile LC; Rx only; Indicated for the replacement of malfunctioning native or aortic and mitral heart valves. Recall # Z-1225-2009;
b) Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s T505C2501, T505C2101, T505U25ID , T505C2301, T505C2301, T505C2501, T505C2101, T510C29ID, T510C25ID, and T510C27ID; Sterile LC; Rx only; Indicated for the replacement of malfunctioning native or aortic and mitral heart valves. Recall # Z-1226-2009

MANUFACTURER: Recalling Firm: Medtronic Inc. Minneapolis, MN, by letter dated January 26, 2009. Manufacturer: The Heart Valve Division Medtronic Cardiovascular Surgery, Santa Ana, CA. Firm initiated recall is ongoing.

REASON: Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.

PRODUCT: HemoSense INRatio2 Prothrombin Time Monitor. The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. Recall # Z-1256-2009

MANUFACTURER: HemoSense Inc San Jose, CA, by letter dated December 19, 2008. Firm initiated recall is ongoing.

REASON: INRadio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result.

PRODUCT: Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems. Recall # Z-1396-2009

MANUFACTURER: Beckman Coulter Inc. Brea, CA, by letter on October 8, 2007. Firm initiated recall is complete.

REASON: Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determined that the total imprecision for the Access Myoglobin Reagent is greater than or equal to 10% across the expected physiological range rather than the stated claim less than 8%. Based on internal test data, this change should not have significant effect to risk classification of patients with acute coronary syndrome.

PRODUCT:
a) Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile; REF 332187. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing. Recall # Z-1404-2009;
b) Surgidyne S-Vac round fluted channel silicone drain kit, 10 FR, round, full fluted, 4 channel, 28 cm length, 1/8" trocar, contains 10, sterile, 100cc S-Vac silicone bulb evacuator; REF 332263. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing. Recall # Z-1405-2009;

MANUFACTURER: Aspen Surgical Products, Inc, Caledonia, MI, by letter dated April 13, 2009. Firm initiated recall is ongoing.

REASON: An adaptor, which may be required when connecting the drain to an external device, was not included in the package.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 27, 2009:

CLASS II

PRODUCT: Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel biplane systems with a full sized lateral plane to cover lateral anatomy without requiring multiple contrast injections and radiation exposures. The product is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and interventional cardiac angiography procedures. These systems can be operated in a mobile or fixed site environment. Recall # Z-1195-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC. Waukesha WI, by letter dated February 2, 2009.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of a potential image storage failure on Innova 2121 IQ/ 3131 IQ cardiovascular imaging systems that may impact patient safety. This intermittent communication failure on the image storage chain may result in the following situations: Record abort, Record not available, Fluorostore function not available, Review not available, Boot/Reset failure. Fluoroscopy imaging function remains available to continue the examination, however: The images already acquired may either not be reviewable or the record of images may not be possible. This intermittent failure may result in an additional exposure to patient of X-ray sometimes with iodine (depending on Health Care Professional decision).

PRODUCT: Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. Recall # Z-1196-2009
MANUFACTURER: Recalling Firm: Abbott Diabetes Care, Alameda, CA, by telephone beginning November 1, 2008. Manufacturer: Benchmark Electronics, Rochester, MN. Firm initiated recall is complete.
REASON: The product has the Units of Measure set to mmol/L rather than mg/dL. The blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

PRODUCT: HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The defibrillator/monitor is a fully featured defibrillator intended for use by qualified medical personnel trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment. Recall # Z-1199-2009
MANUFACTURER: Philips Healthcare Inc. Andover, MA, by letter dated March 2009. Firm initiated recall is ongoing.
REASON: Rotary energy select switch in affected M4735A devices may fail and prevent the user from turning the device on, rendering the device unusable for monitoring and defibrillation therapy.

PRODUCT:
a) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN Description M001271770 FLEXIMA NEPH FIRM 8F/25CM M001271780 FLEXIMA NEPH FIRM 10F/25CM M001271790 FLEXIMA NEPH REG 8F/25CM M001271800 FLEXIMA NEPH REG 10F/25CM M001271810 FLEXIMA NEPH REG 12F/25CM M001271820 FLEXIMA NEPH REG 14F/25CM M001271830 FLEXIMA NEPH SOFT 10F/25CM M001271840 FLEXIMA NEPH SOFT 12F/25CM M001271850 FLEXIMA NEPH SOFT 14F/25CM M001281790 FLEXIMA NEPHROSTOMY 8/25 TT M001281800 FLEXIMA NEPHROSTOMY 10/25 TT M001281810 FLEXIMA NEPHROSTOMY 12/25 TT M001281820 FLEXIMA NEPHROSTOMY 14/25 TT M001271860 FLEXIMA NEPH 8F/25CM REG KIT M001271870 FLEXIMA NEPH 10F/25CM REG KIT M001271880 FLEXIMA NEPH 12F/25CM REG KIT M001271890 FLEXIMA NEPH 14F/25CM REG KIT M001271900 FLEXIMA NEPH 8F/25CM FIRM KIT M001271910 FLEXIMA NEPH 10F/25CM FIRM KIT M001281650 FLEXIMA NEPH 8/25 TEMP TIP KIT M001281660 FLEXIMA NEPH/10/25 TEMPTIP KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.  Recall # Z-1331-2009;
b) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN Description M001271240 FLEXIMA APDL FIRM 10F/25CM M001271310 FLEXIMA APDL FIRM 6.3F/25CM M001271320 FLEXIMA APDL FIRM 8F/25CM M001271330 FLEXIMA APDL REG 6.3F/25CM M001271340 FLEXIMA APDL REG 8F/25CM M001271350 FLEXIMA APDL REG 10F/25CM M001271380 FLEXIMA APDL REG 12F/25CM M001271390 FLEXIMA APDL REG 14F/25CM M001271460 FLEXIMA QUICKSTICK LL 8FR M001271470 FLEXIMA QUICKSTICK LL 10FR M001275060 APDTL/7.3FR FLEXIMA SINGLE TT M001275080 APDLTL/7.3FR FLEXIMA SINGLE TT M001281340 FLEXIMA APDL 8/25 TT M001281350 FLEXIMA APDL 10/25 TT M001281380 FLEXIMA APDL 12/25 TT M001281390 FLEXIMA APDL 14/25 TT M001271960 FLEXIMA APDL 8FR REG KIT M001271970 FLEXIMA APDL 10FR REG KIT M001271980 FLEXIMA APDL 8FR FIRM KIT M001271990 FLEXIMA APDL 10FR FIRM KIT M001275070 APDTL/7.3FR FLEXIMA KIT TT M001275010 APDLTL/7.3 FLEXIMA FIRM SINGLE M001275090 APDLTL/7.3FR FLEXIMA KIT TT M001275030 FLEXIMA APDLTL/7/30 STAND KIT M001275050 FLEXIMA APDLTL/7/30 DELUXE KIT Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1332-2009;
c) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN Description M001271540 FLEXIMA BILIARY FIRM 8F/35CM M001271550 FLEXIMA BILIARY FIRM 10F/35CM M001271560 FLEXIMA BILIARY REG 8F/35CM M001271570 FLEXIMA BILIARY REG 10F/35CM M001271580 FLEXIMA BILIARY REG 12F/35CM M001271590 FLEXIMA BILIARY REG 14F/35CM M001271600 FLEXIMA BILIARY SOFT 10F/35CM M001271610 FLEXIMA BILIARY SOFT 12F/35CM M001271620 FLEXIMA BILIARY SOFT 14F/35CM M001281560 FLEXIMA BILIARY 8/35 TT M001281570 FLEXIMA BILIARY 10/35 TT M001281580 FLEXIMA BILIARY 12/35 TT M001281590 FLEXIMA BILIARY 14/35 TT M001271630 FLEXIMA BIL 8F/35CM FIRM KIT M001271640 FLEXIMA BIL 10F/35CM FIRM KIT M001271650 FLEXIMA BIL 8F/35CM REG KIT M001271660 FLEXIMA BIL 10F/35CM REG KIT Single Use Only, Sterilized with Ethylene Oxide Gas. Recall # Z-1333-2009;
d) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001205501 SACKS SS/6FR/28CM (BX/5) M001205521 SACKS SS/8.3FR/28CM (BX/5) Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1334-2009;
e) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001221000 AA/8/30 M001221010 AA/10/30 M001221020 AA/12/30 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z1335-2009;
f) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001201050 VSKCL-12 M001201060 VSKCL-14 M001202020 VSDCL-12 M001202030 VSDCL-14 M001203060 VSCL-12 M001203070 VSCL-14 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1336-2009;
g) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001272600 FLEXIMA BILIARY REG RO 8F/35CM M001272610 FLEXIMA BILIARY REG RO 10F/35CM M001272620 FLEXIMA BILIARY REG RO 12F/35CM M001272630 FLEXIMA BILIARY REG RO 14F/35CM M001272640 FLEXIMA BILIARY FIRM RO 8F/35CM M001272650 FLEXIMA BILIARY FIRM RO 10F/35CM M001272660 FLEXIMA BILIARY SOFT RO 10F/35CM M001272670 FLEXIMA BILIARY SOFT RO 12F/35CM M001282600 FLEXIMA BILIARY TT RO 8F/35CM M001282610 FLEXIMA BILIARY TT RO 10F/35CM Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1337-2009;
h) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001245260 VTCG/8/25 M001245270 VTCG/10/25 M001245280 VTCG/12/25 M001245290 VTCG/14/25 M001245300 VTCGK/8/25 M001245310 VTCGK/10/25 M001245320 VTCGK/12/25 M001245061 APD/LPG/6/25 (BX/5) M001245071 APDL/8.3/20 (BOX/5) M001245081 APD/LPG/10/25 (BX/5) M001245130 VSCD/LPG/12/25 M001245140 VSCD/LPG/14/25 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1338-2009;
i) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001225240 VTC FIRM KIT 8 M001225140 VTC FIRM 8 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1339-2009;
j) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description 435428-01 M001273030 FLEXIMA VSCL REG 12FR/35CM M001273040 FLEXIMA VSCL REG 14FR/35CM M001273090 FLEXIMA VSDC REG LOOP 12/35KIT M001273100 FLEXIMA VSDC REG LOOP 14/35KIT M001273150 FLEXIMA VSCL FIRM 12FR/35CM M001273160 FLEXIMA VSCL FIRM 14FR/35CM M001273210 FLEXIMA VSDC FIRM LOOP 12/35 M001273220 FLEXIMA VSDC FIRM LOOP 14/35 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1340-2009;
k) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001213060 VSCTT/LOOP/12/35 M001213070 VSCTT/LOOP/14/35 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1341-2009;
l) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001221360 I/E-8/22 M001221370 I/E-8/24 M001221380 I/E-8/26 M001221390 I/E-8/28 M001221400 I/E-10/22 M001221410 I/E-10/24 M001221420 I/E-10/26 M001221430 I/E-10/28 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1342-2009;
m) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M001231360 IE TEMP TIP 8/22 M001231370 IE TEMP TIP 8/24 M001231380 IE TEMP TIP 8/26 M001231390 IE TEMP TIP 8/28 M001231400 IE TEMP TIP 10/22 M001231410 IE TEMP TIP 10/24 M001231420 IE TEMP TIP 10/26 M001231430 IE TEMP TIP 10/28 Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1343-2009;
n) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M0064102020 Percuflex All Purpose Drainage Catheters wit Fader Tip and Locking Pigtail 8 Fr M0064102030 Percuflex All Purpose Drainage Catheters with Fader Tip and Locking Pigtail 10 Fr Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1344-2009;
o) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN # Description M0064102040 Percuflex Locking Loop Nephrostomy Catheters with Fader Tip 8 Fr M0064102050 Percuflex Locking Loop Nephrostomy Catheters with Fader Tip 10 Fr M0064102060 Percuflex Locking Loop Nephrostomy Catheters with Fader Tip 12 Fr M0064103040 Percuflex Locking Loop Nephrostomy Catheters with Fader Tip (Kit) 8 Fr M0064103050 Percuflex Locking Loop Nephrostomy Cateters with Fader Tip (Kit) 10 Fr Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1345-2009;
p) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M0064101110 Percutaneous Nephrostomy Catheters Percutaneous with Locking Loop 8 Fr M0064101120 Nephrostomy Catheters with Locking Loop 10 Fr Single Use Only, Sterilized with Ethylene Oxide Gas. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1346-2009;
q) Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# Description M0064101260 Percutaneous Combination Stent/Nephrostomy Catheter 8 Fr Single Use Only, Sterilized with Ethylene Oxide Gas, Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract. Recall # Z-1347-2009
MANUFACTURER: Recalling Firm: Boston Scientific Corp. Maple Grove, MN, by letter dated March 18, 2009. Manufacturer: Boston Scientific Corp. Spencer, IN. Firm initiated recall is ongoing.
REASON: Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient.

PRODUCT: a) Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Standard as follows: v.8.04.02.10, catalog no. 04785550001; v.8.04.03, catalog no. 04785550002; and v.8.06.02, catalog no. 05108993001. The device is used to interface hospital LIS systems with Roche c 6000 analyzers and allows order and result communication to occur between the two systems.. Recall # Z-1393-2009;
b) Roche cobas 6000 analyzer series (cobas c 501 and cobas e 601) Middleware Solutions Instrument Manager Server as follows: v.8.04.02.10, catalog no. 04785568001; v.8.04.03.01, catalog no. 04785568002; and v.8.06.02, catalog no. 05109019001. The device is used to interface hospital LIS systems with Roche c 6000 analyzers and allows order and result communication to occur between the two systems. Recall # Z-1394-2009
MANUFACTURER: Recalling Firm: Roche Diagnostics Corp. Indianapolis, IN, by letter dated April 1, 2009. Manufacturer: Data Innovations, Inc. South Burlington, VT. Firm initiated recall is ongoing.
REASON: Some data alarm flags do not transfer from the analyze to the laboratory information system, since not all data flags are recognized by the instrument manager/middleware.

PRODUCT: Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000. Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus. Recall # Z-1395-2009
MANUFACTURER: Bio-Rad Laboratories, Inc. Hercules, CA, by telephone, fax and letter on December 10, 2008. Firm initiated recall is ongoing.
REASON: The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.

PRODUCT: Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus Recall # Z-1400-2009
MANUFACTURER: Recalling Firm: Remel, Inc. Lenexa, KS, by letter dated November 20, 2008, by telephone beginning December 30, 2008 to January 11, 2009 and by letters dated March 16, 2009. Manufacturer: Remel Europe Ltd. Dartford, England. Firm initiated recall is ongoing.
REASON: The lots may exhibit false positive reactions with strains of Staphylococcus epidermidis that may result in the mis-identification of Staphylococcus aureus.

PRODUCT: 
a) In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children. Recall # Z-1408-2009;
b) In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S. Used with Synthes' Rapid Resorbable Fixation System this is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children. Recall # Z-1409-2009
MANUFACTURER: Recalling Firm: Synthes Spine, West Chester, PA, by letter on April 6, 2009. Manufacturer: Synthes (USA), Monument, CO. Firm initiated recall is ongoing.
REASON: Sterility may be compromised due to a ineffective package design.

PRODUCT: Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6276-1-025, Catalog number 6276-1-219, and Catalog number 6276-1-325. Sterile. Intended Use: For primary or revision total hip arthroplasty and severe proximal bone loss. Stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. Conditions for which product may be appropriate for use: rheumatoid arthritis, correction of deformity, non-inflammatory degenerative joint disease, revision surgery, treatment of non-union, fracture of proximal femur with head involvement. Recall # Z-1410-2009
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letters on April 2, 2009. Manufacturer: Stryker Ireland, LTD, Orthopedics, Carrigtohill, Ireland. Firm initiated recall is ongoing.
REASON: Packaging burst test values for the Restoration Modular Cone Body family were found to be incorrectly transferred from the finalized validation to the work specification. Testing showed that burst test results for recalled products fell below the validated parameters.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 20, 2009:

CLASS I

PRODUCT: SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates. Model Number 4002 and Model Number 4003. Recall # Z-1411-2009.
MANUFACTURER: Respironics, Inc. Murrysville, PA, by letter dated April 23, 2009. Firm initiated recall is ongoing.
REASON: Audible alarm failure.

CLASS II
****CORRECTION****
Enforcement Report for May 13, 2009, Ethicon, Inc. Recall #’s Z-1310-2009 through Z-1316-2009. The following changes were made to the above recall in the Code Information:
1) Lot # APM668, APZ284 , APZ627, APZ895, APZ096, APZ076, APM085, APM270, APM271, AP2312, AP2423, AP2462, APZ117, APM842, APZ756, APZ116, APZ244, AP2566, AP2597, APZ460, AP2634, AP2519, APZ291, APZ778, APZ782, AP2589, APM525, APM400, APM482, AP6072, APZ014, APM324, APM938, APZ276, APM031, APM214, APZ402, AP2093, APZ961, APZ410, APZ856, AP6080, APZ472, APM382, APZ167, APZ337, APZ932, APZ459, APZ766, APZ767, AP6077, AP2539, AP2615, AP2407, and APZ195.
2) Lot # AP2507, AP2695, AP2599, AP2501, APM984, APZ416, APZ191, APZ804, APM982, APZ289, APZ031, AP6025, AP6083, APM591, APZ372, and APZ254.
3) Lot # APZ334, APM964, APM965, APZ063, APZ155, APZ156, and APZ476;
5) Lot # Expiration Date APM091 2013-07-31 12:00AM APM861 2013-07-31 12:00AM APZ105 2013-07-31 12:00AM AMK590 2013-07-31 12:00AM APZ721 2013-07-31 12:00AM APZ098 2013-07-31 12:00AM APZ283 2013-07-31 12:00AM APM692 2013-07-31 12:00AM APM753 2013-07-31 12:00AM AP6005 2013-07-31 12:00AM APM748 2013-07-31 12:00AM APZ367 2013-07-31 12:00AM APM298 2013-07-31 12:00AM APZ245 2013-07-31 12:00AM AP6053 APZ644 2013-07-31 12:00AM APM524 2013-07-31 12:00AM APZ908 2013-07-31 12:00AM AP6061 2013-07-31 12:00AM APM635 2013-07-31 12:00AM APZ126 2013-07-31 12:00AM APZ298 2013-07-31 12:00AM APZ153 2013-07-31 12:00AM APZ381 2013-07-31 12:00AM AP2315 2013-07-31 12:00AM AP2333 2013-07-31 12:00AM AP2331 2013-07-31 12:00AM AP2332 2013-07-31 12:00AM AP2241 2013-07-31 12:00AM AP2355 2013-07-31 12:00AM APM221 2013-07-31 12:00AM APM844 2013-07-31 12:00AM;
6) Lot number Expiration Date APM639 2010-07-31 12:00AM APM937 2010-07-31 12:00AM APZ507 2010-07-31 12:00AM APM952 2010-07-31 12:00AM APM660 2010-07-31 12:00AM APM651 2010-07-31 12:00AM APM726 2010-07-31 12:00AM APM599 2010-07-31 12:00AM; 
The lots numbers for Products 4, 7, & 8 stayed the same.

PRODUCT: Roche MagNA Pure LC Workstation. Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material such as whole blood, serum, blood cells, culture cells, tissue, bacteria and fungi. Recall # Z-1255-2009
MANUFACTURER: Recalling Firm: Roche Diagnostics Corp. Indianapolis IN, by letter dated February 9, 2009. Manufacturer: Roche Instrument Center AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
REASON: Protruding screw threads may cut the user when cleaning the interior of the instrument.

PRODUCT: Zimmer Sirus Intramedullary nail for tibia, cannulated, diameter 12 L, 330 mm, sterile, Zimmer GmbH, Winterthur, Switzerland; REF 02.02631.233. The device is used in orthopedic trauma surgeries for stabilization of tibial bone fractures. Recall # Z-1261-2009
MANUFACTURER: Recalling Firm: Zimmer Inc. Warsaw, IN, by telephone on March 23, 2009 and letter dated March 31, 2009. Manufacturer: Zimmer GMBH, Winterthur, Switzerland. Firm initiated recall is ongoing.
REASON: The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.

PRODUCT: Carina Home Ventilator. The device is used as a continuous respirator/ventilator for home use. Catalog Numbers 5704757 and 5704758. Recall # Z-1263-2009
MANUFACTURER: Draeger Medical, Inc. Telford, PA, by letters dated January 2009 and January 22, 2009.Manufacturer: Drager HomeCare, Best, Netherlands. Firm initiated recall is ongoing.
REASON: The device may not generate a pilot line disconnect alarm if the pilot line becomes disconnected, which may potentially result in a substantial reduction in tidal volume delivery.

RODUCT: Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 925474325, 925654225, 925654325, 925754325, 925754335, and 92M774325. Intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of a hospital or clinic where low-end monitoring systems are needed. Recall # Z-1326-2009
MANUFACTURER: Smiths Medical PM, Inc. Waukesha, WI, by letters dated December 22, 2008 and January 16, 2009. Firm initiated recall is ongoing.
REASON: Recent improvements were made to the Advisor case plastic resulting in the inserts being deeply embedded into the plastic. This affects the ability of the monitor to be adequately secured on the wall mount bracket or roll stand bracket, resulting in the monitor falling off. There have been no adverse events or injuries reported.

PRODUCT: Centricity TriWin Laboratory Information System; The Centricity TriWin Laboratory product is a laboratory information system. It is designed to facilitate the general clinical, anatomic pathology, and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. Recall # Z-1397-2009
MANUFACTURER: Recalling Firm: GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated November 17, 2008. Manufacturer: Triple G Systems Group, Inc. Markham, Canada. Firm initiated recall is ongoing.
REASON: A software defect in the Centricity Lab (TriWin) product may incorrectly link patient information to a wrong report. Also, when viewing results in Patient Viewer, and a coagulation result is higher or lower than the linearity limit, then all of the results following the higher or lower result will show the same result as the first flagged result.

CLASS III

PRODUCT: Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum. Recall # Z-1327-2009
MANUFACTURER: Diagnostic Chemicals, Ltd. Charlottetown Prince Edward Island, Canada, by letter on March 14, 2008. Firm initiated recall is complete.
REASON: Precipitate in product may cause elevated background absorbance interference.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 13, 2009:

CLASS I

PRODUCT: Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box. Fluorescence immunoassay kit to be used with the Triage Meter for the quantitative determination of myoglobin, creatine kinase MB fraction (CK-MB), and troponin I in EDTA whole blood and plasma specimens. These three cardiac biomarkers are used as an aid in the diagnosis of myocardial infarction (injury). Recall # Z-1391-2009
MANUFACTURER: Biosite Inc. San Diego, CA, by letter dated April 28, 2009 via fax, e-mail or direct mail. Firm initiated recall is ongoing.
REASON: The use of the affected lot may lead to reporting falsely low values for troponin I and myoglobin, possibly resulting in missed or incorrect diagnosis.

CLASS II

PRODUCT: KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, UPN 00858196001161.  For use in spinal surgery. Recall # Z-1209-2009
MANUFACTURER: Recalling Firm: Medtronic Spine LLC, formerly Kyphon Inc. Sunnyvale, CA, by e-mail on February 4, 2009 and by letter dated February 9, 2009.
Manufacturer: Medtronic Kyphon Mfg Neuchatel, Neuchatel, Switzerland. Firm initiated recall is ongoing.
REASON: Product not sterile: 10 units were released for distribution without undergoing sterilization process.

PRODUCT: GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6 , 5.0.7, 5.0.8 and 4.1. The CIC Pro" Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro Central Station is intended to collect information from a network and display this data. This data included physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from GE Healthcare Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information central station. Beat to beat patient information for all parameters and waveforms from he bedsides and telemetry systems can be displayed. The CIC Pro Clinical Information Center central station supports the ability to access information from GE Medical Systems Information Technologies products in web browser format. Additionally, the CICC Pro clinical Information central station supports the ability to access patient information collected from the unity network and stored on a network server. Recall # Z-1232-2009
MANUFACTURER: Recalling Firm: General Electric Medical Systems Information Technology, Wauwatosa, WI, by letter dated February 27, 2009.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON: Potential network time issues associated with the time change aspects of certain CARESCAPE CIC Pro" software versions. These issues may impact patient safety. No reported patient injuries or illnesses for the use of this device in conjunction with this device correction.

PRODUCT: Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full field digital mammography system. Recall # Z-1233-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc. Malvern, PA, by letter dated December 16, 2008. Manufacturer: Siemens Ag Healthcare Sector, Erlangen, Germany. Firm initiated recall is ongoing.
REASON: Image may appear dark, requiring repeat image acquisition.

PRODUCT: Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critical ventilator care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport. Recall # Z-1252-2009
MANUFACTURER: Recalling Firm: Maquet Inc. Bridgewater, NJ, by letter dated March 23, 2009. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
REASON: The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.

PRODUCT:
a) AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as radiographic and fluoroscopic imaging device. Recall # Z-1253-2009;
b) AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic imaging device. Recall # Z-1254-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc. Malvern, PA, by letter dated January 8, 2009. Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON: During interventional use and applications, the possibility exists for liquids to enter the systems.

PRODUCT: Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07. A reusable cutting instrument that is used in total knee arthroplasty surgery. Recall # Z-1262-2009
MANUFACTURER: Zimmer Inc. Warsaw, IN, by letter dated March 13, 2009. Firm initiated recall is ongoing.
REASON: The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.

PRODUCT:
a) Coated VICRYL (Polyglactin 910) Suture, Sutures are intended for general soft tissue approximation and/or ligation. Recall # Z-1309-2009;
b) Coated VICRYL Plus Antibacterial (polyglactin 910) Suture; Sutures are intended for general soft tissue approximation and/or ligation. Recall # Z-1310-2009;
c) MONOCRYL (poliglecaprone 25) Suture, Sutures are intended for general soft tissue approximation and/or ligation. Recall # Z-1311-2009;
d) MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture; Sutures are intended for general soft tissue approximation and/or ligation. Recall # Z-1312-2009;
e) PDS II (polydioxanone) Suture, Sutures are intended for general soft tissue approximation and/or ligation. Recall # Z-1313-2009;
f) PDS Plus Antibacterial (polydioxanone) Suture; Sutures are intended for general soft tissue approximation and/or ligation. Recall # Z-1314-2009;
g) Orthocord Blue Braided Composite Suture, Meets USP and EP, except for diameter. Sutures are intended for general soft tissue approximation and/or ligation. Recall # Z-1315-2009;
h) Orthocord Suture; Sutures are intended for general soft tissue approximation and/or ligation. Recall # Z-1316-2009
MANUFACTURER: Recalling Firm: Ethicon, Inc. Somerville, NJ, by letters on February 2, 2009. Manufacturer: Ethicon Inc. San Angelo TX. Firm initiated recall is ongoing.
REASON: Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

PRODUCT: Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma. Recall # Z-1328-2009
MANUFACTURER: Nova Biomedical Corp. Waltham, MA, by telephone, e-mail and fax beginning August 11, 2008. Firm initiated recall is ongoing.
REASON: Erroneous, low creatinine results on CCX analyzer.:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 6, 2009:

CLASS II

PRODUCT:
a) Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard Catheter, 5 per box, sterile; REF 525-125. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1182;
b) Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile; REF 525-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1183;
c) Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen Catheter and Luer Lock Tubing Set, 5 per box, sterile; REF 525-158. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1184;
d) Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile; REF 525-350. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1185;
e) Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2 Site Catheter Set, 5 per box, sterile; REF 540-25. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1186;
f) Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2 Site Catheter Set, 5 per box, sterile; REF 540-50. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1187;
g) Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile; REF 540-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1188;
h) Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard Catheter, 5 per box, sterile; REF 521-125. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1189;
i) Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile; REF 521-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1190;
j) Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-Site Catheter Set, 5 per box, sterile; REF 525-25. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1191;
k) Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-Site Catheter Set, 5 per box, sterile; REF 525-50. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1192;
l) Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile, REF 540-350. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1193;
m) Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile; REF 541-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1194
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corp, Portage, MI, by letter dated February 11, 2009. Manufacturer: Stryker Puerto Rico, Inc, Arroyo, PR. Firm initiated recall is ongoing.
REASON: An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.

PRODUCT: Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems, Recall # Z-1197-2009
MANUFACTURER: Recalling Firm: Beckman Coulter Inc, Brea, CA, by letter dated January 10, 2008. Manufacturer: Beckman Coulter Inc, Fullerton, CA. Firm initiated recall is complete.
REASON: Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibration for PSA is not currently approved in the United States.

PRODUCT: Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Recall # Z-1208-2009
MANUFACTURER: Wright Medical Technology Inc, Arlington, TN, by letters on March 11, 2009. Firm initiated recall is ongoing.
REASON: The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated.

PRODUCT: Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU): C106KL0050A20 (12 posts) and C117K00000020 (4 posts), Swiss Made, Recall # Z-1234-2009
MANUFACTURER: Recalling Firm: Dentsply Worldwide Headqrt, York PA, by letter and e-mail on March 20, 2009 Manufacturer: Maillefer Instruments Holding SA, Ballaigues, Switzerland. Firm initiated recall is ongoing.
REASON: The product is manufactured with a left-hand thread instead of a right hand thread. This error could cause tooth breakage if the posts were removed without knowing that the threads were reversed.

PRODUCT: Syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063, Recall # Z-1235-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern PA, by visit in November 2008. Manufacturer: Siemens Ag Healthcare Sector, Erlangen, Germany. Firm initiated recall is ongoing.
REASON: Incorrect and/or incomplete data: Several potential safety issues while working with the syngo Image product including, but not limited to, data loss, errors in patient data due to different patient IDs, delays in image availability, inaccurate results during image measurements, incorrect review or diagnosis of displayed or printed images, measurement inaccuracies from the host modality and image scaling problems prior to system calibration and alignment.

PRODUCT:
a) Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard Catheter, 5 per box, sterile; REF 525-125. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1182;
b) Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile; REF 525-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1183;
c) Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen Catheter and Luer Lock Tubing Set, 5 per box, sterile; REF 525-158. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1184;
d) Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile; REF 525-350. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1185;
e) Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2 Site Catheter Set, 5 per box, sterile; REF 540-25. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1186;
f) Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2 Site Catheter Set, 5 per box, sterile; REF 540-50. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1187;
g) Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile; REF 540-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1188;
h) Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard Catheter, 5 per box, sterile; REF 521-125. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1189;
i) Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile; REF 521-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1190;
j) Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-Site Catheter Set, 5 per box, sterile, Stryker; REF 525-25. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1191;
k) Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-Site Catheter Set, 5 per box, sterile; REF 525-50. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management. Recall # Z-1192;
l) Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5 per box, sterile; REF 540-350. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1193;
m) Stryker PainPump2, 400 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 541-155. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management, Recall # Z-1194
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corp, Portage, MI, by telephone and letter dated February 11, 2009. Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. Firm initiated recall is ongoing.
REASON: An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.

PRODUCT: Cerner Bridge Medical Transfusion Administration and Specimen Collections, Recall # Z-1236-2009
MANUFACTURER: Cerner Corp, Kansas City, MO, by letter dated January 15, 2009. Firm initiated recall is ongoing.
REASON: Specimen labels printing incorrect patient demographics.

PRODUCT: Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1. Recall # Z-1237-2009
MANUFACTURER: Cardinal Health 303 dba Cardinal Health, San Diego, CA, by letter on March 11, 2009. Firm initiated recall is ongoing.
REASON: The Alaris PCA module can potentially infuse above or below the intended infusion dose.

PRODUCT: syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Picture Archiving and communications system. Recall # Z-1266-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter dated 02/09/2009. Manufacturer: Siemens Ag Healthcare Sector, Erlangen, Germany. Firm initiated recall is ongoing.
REASON: An issue concerning archived image data that is sporadically saved with corrupted data may occur. This issue may occur when syngo Imaging is configured to archive image data on a network file system (NFS) connected via a connected archive (Mount Point Solution).

PRODUCT: Lumi 8 Intense LED Light Facial System, Mode of Operation: Operation with Intermittent/continuous load, Visible and Invisible LED Radiation, Class 3R LED Product, Refer to IEC 60825-2001 for further information., Input: 100 -230 V AC 50/60 HZ Power Input: 1509 V A....Protective Eyewear required Wavelength 590 & 630 nm. Recall # Z-1308-2009
MANUFACTURER: Recalling Firm: Sybaritic, Inc, Bloomington, MN, by letter and telephone on June 18, 2008. Manufacturer: Beijing Top Laser Tech Co., Ltd, Beijing, China. Firm initiated recall is ongoing.
REASON: Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.

PRODUCT: Hill-Rom TotalCare Bed, Model P1900. The TotalCare (R) Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare (R) Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post. Recall # Z-1317-2009
MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated March 9, 2009. Firm initiated recall is ongoing.
REASON: An e-ring may not have been installed during production, which could result in an inability to latch the siderail.

PRODUCT:
a) Tri-State Centurion Endoscopy Tray, sterile, 10 per case; Reorder MNS4635. Recall # 1319;
b) Tri-State Centurion Laceration Tray - SnagFree, sterile, 16 per case; Reorder SUT12265. Recall # Z-1320;
c) Tri-State Centurion Incision and Drainage Tray, sterile, 20 per case; Reorder ID615. Recall # Z-1321;
d) Tri-State Centurion Plastic Laceration Set, sterile, 16 per case; Reorder SUT3390. Recall # Z-1322
MANUFACTURER: Recalling Firm: Tri-State Hospital Supply Corp, Howell, MI, by letter dated January 14, 2009. Manufacturer: Tri-State Hospital Supply Corp, Salisbury, NC. Firm initiated recall is ongoing.
REASON: Compromised sterility, as the package seals may be inadequate.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 29, 2009:

CLASS II

PRODUCT:
a) AxSYM HBsAg Reagent Pack; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes); list 9B01-20; Recall # Z-1046-2009;
b) AxSYM CMV IgG Reagent Pack; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomegalovirus in human serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus; list 4B47-20; Recall # Z-1047-2009;
c) AxSYM CORE 2.0 Reagent Pack; AxSYM CORE 2.0 is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of total antibodies (IgG and IgM) to hepatitis B virus core antigen (anti-HBc) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes containing lithium heparin); list 8B88-20; Recall # Z-1048-2009;
d) AxSYM Folate Reagent Pack; AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma or red blood cells on the AxSYM System; list 3C81-20; Recall # Z-1049-2009;
e) AxSYM Myoglobin Reagent Pack, AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System; list 3E43-20; Recall # Z-1050-2009;
f) AxSYM Troponin-I ADV Reagent Pack,; AxSYM Troponin-I ADV is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnI) in human serum or plasma on the AxSYM System; list 2J44-22; Recall # Z-1051-2009
MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by letter on January 19, 2009. Firm initiated recall is ongoing.
REASON: Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.

PRODUCT: Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Number 08H00-01; Recall # Z-1069-2009
MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letter on December 10, 2008. Firm initiated recall is ongoing.
REASON: Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.

PRODUCT: Operon Electrical Operating Room Table. The device is used as an electrical operating room table; Recall # Z-1123-2009
MANUFACTURER: Recalling Firm: Berchtold Corp., N Charleston, SC, by letter dated February 3, 2009. Manufacturer: Berchtold Medizin Elektronik, Tuttlingen, Germany. Firm initiated recall is ongoing.
REASON: Difficulty in pressing the button needed to release a bed part resulted in an injury to a caregiver’s finger which became stuck in metal latch under the gas cylinder of the bed piece.

PRODUCT: a) Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240, and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma; Recall # Z-1200-2009;
b) Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma; Recall # Z-1201-2009
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter dated January 29, 2009. Firm initiated recall is ongoing.
REASON: The R1 reagent has microbial contamination.

PRODUCT: PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108. Intended to establish points of reference that are used in the determination of values in the determination of Lp-PLA2 by the PLAC Test Reagent Kit. Recall # Z-1205-2009
MANUFACTURER: DiaDexus, Inc., South San Francisco, CA, by telephone, letter and e-mail on February 26, 2009. Firm initiated recall is ongoing.
REASON: Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.

CLASS III

PRODUCT: a) Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator; Recall # Z-0994-2009
b) Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator; Recall # Z-0995-2009
MANUFACTURER: Cyberonics, Inc., Houston, TX, by letter on February 7, 2009. Firm initiated recall is ongoing.
REASON: Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference, resulting in the loss of stimulation.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 22, 2009:

CLASS I

PRODUCT:
a) 8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1210-2009;
b) 8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle. Z-1211-2009;
c) 8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1212-2009;
d) 8 Fr 40cc Ultra 8 IAB, IAB-05840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1213-2009;
e) 7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle; Recall # Z-1214-2009;
f) 7.5 Fr 40cc UltraFlex IAB, IAB-06840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1215-2009;
g) 8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1216-2009;
h) 8 Fr 40cc FIBEROPTIX IAB, IAB-05840-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1217-2009;
i) 7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1218-2009;
j) 8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1219-2009;
k) 9 FR 50CC Rediguard IAB, IAB-R950-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1220-2009;
l) ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle., Recall # Z-1221-2009
m) ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1222-2009
MANUFACTURER: Arrow International, Inc., Everett , MA , by letter dated February 2, 2009, February 9, 2009, February 6, 2009 and February 10, 2009. Firm initiated recall is ongoing.
REASON: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.

CLASS II

PRODUCT: Stryker Trio Small Offset Connector Non Sterile; The Trio Spinal Fixation Systems are pedicle screws systems intended for use in providing immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar, and sacral spine: degenerative spondyolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion. Catalog Number 48902015; Recall # Z-0986-2009
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale , NJ , by letter dated September 12, 2006. Manufacturer: Stryker Spine, Cestas, France . Firm initiated recall is complete.
REASON: Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.

PRODUCT: CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette Reservoirs are intended for use with the CADD Ambulatory Infusion Pumps used for delivering drug therapy and anesthesia to patients. The pumps can be used by home care patients and in a healthcare facility, Recall # Z-0987-2009
MANUFACTURER: Recalling Firm: Smiths Medical MD, Inc., Saint Paul , MN , by letter on December 8, 2008. Manufacturer: Smiths Healthcare Manufacturing S.A. De C.V., Tijuana BC , Mexico . Firm initiated recall is ongoing.
REASON: Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due to these leakages.

PRODUCT:
a) Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients but, can also be used in a healthcare facility, Recall # Z-0988-2009;
b) Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients, but can also be used in a healthcare facility, Recall # Z-0989-2009
MANUFACTURER: Smiths Medical MD, Inc., Saint Paul , MN , by letter dated November 20, 2008. Firm initiated recall is ongoing.
REASON: There have been adverse events reported that the amount of Extended Bolus delivered was not accurately displayed by the Pump. The amount of extended Bolus displayed on the Pump Home Screen 2 and in the Bolus Summary Report is less than what was programmed by the user. In these events, the Pumps delivered the correct amount of insulin as programmed by the user. If the user programs an additional Bolus based solely on the extended Bolus delivered amount displayed on the Bolus Summary Report or Home Screen 2, there is a risk of hypoglycemia.

PRODUCT: a) GE Healthcare Infinia, Model Numbers: a) ASM000886, b) ASM001333, c) ASM001391, d) ASM001465, e) ASM001473, f) ASM001620, g) ASM500016, h) H3000WM, i) H3000WT, j) H3000WY and k) SYS000041. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1001-2009;
b) GE Healthcare Infinia Hawkeye, Model Numbers: a) H3000WR, b) H3000WW, c) H3000WZ, d) H3000YM and e) H3000YS. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1002-2009;
c) GE Healthcare Infinia Hawkeye 4, Model Numbers: a) 5178728, b) ASM500060, c) H3000WC and d) H3000WD. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1003-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha , WI , by letter dated April 2008. Manufacturer: GE Medical System, Tirat Hacarmel 30200 , Israel . Firm initiated recall is ongoing.
REASON: GE Healthcare has recently become aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety. It was reported at a customer site that the pressure used to activate the Pressure Sensitive Device (PSD) should be lowered and that the body contouring software requires correction to prevent possible patient injury during operation. This resulted in a patient receiving a broken nose during a whole body scan while using the Auto Body Contour software option.

PRODUCT: Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures, Recall # Z-1004-2009
MANUFACTURER: Smith & Nephew Inc., Memphis , TN , by e-mail dated November 24, 2008. Firm initiated recall is ongoing.
REASON: Liners measuring 28 mm ID and were mismarked as 32 mm.

PRODUCT:
a) AxSYM HBsAg Reagent Pack; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes); list 9B01-20, Recall # Z-1046-2009;
b) AxSYM CMV IgG Reagent Pack; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomegalovirus in human serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus; list 4B47-20, Recall # Z-1047-2009;
c) AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0 is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of total antibodies (IgG and IgM) to hepatitis B virus core antigen (anti-HBc) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes containing lithium heparin); list 8B88-20, Recall # Z-1048-2009;
d) AxSYM Folate Reagent Pack; AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma or red blood cells on the AxSYM System; list 3C81-20, Recall # Z-1049-2009;
e) AxSYM Myoglobin Reagent Pack; AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System; list 3E43-20, Recall # Z-1050-2009;
f) AxSYM Troponin-I ADV Reagent Pack; AxSYM Troponin-I ADV is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnI) in human serum or plasma on the AxSYM System; list 2J44-22, Recall # Z-1051-2009
MANUFACTURER: Abbott Laboratories, Abbott Park , IL , by letter on January 19, 2009. Firm initiated recall is ongoing.
REASON: Defective caps; Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.

PRODUCT: a) AxSOS T8 Screwdriver, 3.0mm Locking Set; REF 702746. This product is non sterile. The screwdrivers of the AxSOS system are multiple use instruments used to insert screws into bones, Recall # Z-1062-2009;
b) AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set; REF 702749. This product is non sterile. The torque limiter is used for final tightening locking screws to the plate in order to avoid over tightening of the locking screws, Recall # Z-1063-2009
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah , NJ , by letters on November 24, 2008. Manufacturer: Stryker Trauma AG, Selzach , Switzerland . Firm initiated recall is ongoing.
REASON: Potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.

PRODUCT: a) ALM Prismatic Surgical Light 9551 DF; Maquet SA. ALM Prismatic (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures; Article Number: 567014999, Recall # Z-1153-2009;
b) ALM Prismatic Surgical Light 54004 SF; Maquet SA. ALM Prismatic (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures; Article Number: 567030999, Recall # Z-1154-2009
MANUFACTURER: Recalling Firm: Maquet, Inc., Bridgewater , NJ , by letter dated February 23, 2009. Manufacturer: Maquet S.A. , Orleans Cedex 2, France. Firm initiated recall is ongoing.
REASON: The screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report.

PRODUCT: NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; Outer box labeled as Smiths Medical. The NurseMate Remote Review Station is an integrated review station for the EP WorkMate Computer recording system that allows a separate user to review and edit patient study date stored on the SP Work Mate System and monitor patient data from the EP WorkMate during a Patient study. Smith Medical Part Number: 87-1785-0000, Recall # Z-1156-2009
MANUFACTURER: Recalling Firm: EP Medsystems, Inc., West Berlin , NJ , by letters dated January 16, 2009 and February 13, 2009. Manufacturer: Smiths Medical PM, Inc., Waukesha , WI . Firm initiated recall is ongoing.
REASON: There is a risk that the monitor may not be adequately secured to the stand, resulting in the monitor falling off which may cause injury.

PRODUCT: Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor; Part Number: 0012-00-1589-03 Rev. C, Recall # Z-1198-2009
MANUFACTURER: Datascope Corp - Cardiac Assist Division, Mahwah , NJ , by visit beginning February 4, 2009. Firm initiated recall is complete.
REASON: Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Balloon Pump (IABP) and patient monitor does not provide a signal to the patient monitor.

PRODUCT: 300 microliter CO-RE tips for use with Microlab STAR series instruments, Part Number 235902, 5,760 tips per case. The products are a disposable product that are used with the Microlab STAR series instruments, which are microliter diluting and dispensing devices, Recall # Z-1203-2009
MANUFACTURER: Hamilton Co., Reno , NV , by letter dated December 1, 2008. Firm initiated recall is ongoing.
REASON: Some tips may be occluded and are unable to aspirate or dispense liquid.

PRODUCT:
a) Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1238-2009;
b) Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an Antimicrobial *Heparin Coating) For use with Vigilance Monitor. REF: 139HF75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1239-2009;
c) Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC Thromboshield (An Antimicrobial * Heparin Coating) REF: 139HF75P For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1240-2009;
d) Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC Thromboshield (an Antimicrobial * Heparin Coating); For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 744HF75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1241-2009;
e) Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746F8; For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1242-2009;
f) Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC Thromboshield (An Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746HF8 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1243-2009

MANUFACTURER: Recalling Firm: Edwards Lifesciences, LLC, Irvine , CA , by letters dated February 9, 2009. Manufacturer: Edwards Lifesciences Technology SARL, Anasco, PR. Firm initiated recall is ongoing.

REASON: Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".

PRODUCT: Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. The ViperWire atherectomy guide wire has a shaft diameter of 0.014" and is constructed of stainless steel with a smooth finish and is silicone coated. The spring tip configuration is atraumatic, radiopaque, and can be bent to form a steerable system, Recall # Z-1250-2009
MANUFACTURER: Recalling Firm: Cardiovascular Systems, Inc., Arden Hills , MN , by letters on March 16, 2009. Manufacturer: Lake Region Mfg., Inc., Chaska , MN . Firm initiated recall is complete.
REASON: Devices recalled due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.

PRODUCT: Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-010, 6485-3-018, 6485-3-019, 6485-3-300, 6485-3-308, 6485-3-309, 6485-3-310, 6485-3-318, and 6485-3-319. The Modular Replacement System has been successfully used in clinical in clinical situations where there is extensive bone loss due to tumor resection, and/or failed previous prosthesis, or trauma. These components can be used to replace the proximal femur, the distal femur, the proximal tibia, or to reconstruct the total femur in extreme clinical situations, Recall # Z-1251-2009
MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah , NJ , by letters dated January 30, 2009. Firm initiated recall is ongoing.
REASON: Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components.

CLASS III

PRODUCT: Medtronic Streamline Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Recall # Z-1173-2009
MANUFACTURER: Recalling Firm: Medtronic, Inc., Minneapolis , MN , by letter dated February 6, 2009. Manufacturer: Medtronics France, SA, Fourmies , France . Firm initiated recall is ongoing.
REASON: This lot of product contains incorrect inner pouch labeling; instead of 6495 it is labeled 6500. The outer carton, shelf box labeling, and instructions for use are correct, and the actual product shipped was consistent with the product ordered. No adverse patient effects have been reported.

PRODUCT: Pointe Scientific Direct Bilirubin Reagent Set. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers. a) HB936-120, and b) HB936-294, Recall # Z-1202-2009
MANUFACTURER: Pointe Scientific, Inc., Canton MI , by letter dated February 2, 2009. Firm initiated recall is ongoing.
REASON: The product performance fails due to precipitation of the R2 component.

PRODUCT: Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile; REF 800-0611A and 800-0613A. The device is used for the rapid preparation of platelet-poor-plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow, Recall # Z-1207-2009
MANUFACTURER: Biomet, Inc., Warsaw , IN , by letter dated March 5, 2009. Firm initiated recall is ongoing.
REASON: A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 15, 2009:

CLASS I

PRODUCT: Zoll AED Plus Defibrillator, Recall # Z-1206-2009
MANUFACTURER: ZOLL Medical Corp., World Wide Headquarters, Chelmsford , MA , by letter on February 12, 2009. Firm initiated recall is ongoing.
REASON: Device fails to discharge the defibrillation energy.

CLASS II

PRODUCT:
a) Viasys Healthcare , Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins, Recall # Z-0998-2009;
b) Viasys Healthcare , Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0470 Sonara Bilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins, Recall # Z-0999-2009
MANUFACTURER: Cardinal Health, Inc., Madison , WI , by letter dated January 12, 2009 beginning the week of February 2, 2009 and continuing into week of February 9, 2009. Firm initiated recall is ongoing.
REASON: Internal testing has identified several scenarios where unexpected System lockups, shutdowns or system errors would render the Sonara unavailable for use until the Sonara can be restarted. These issues can be corrected by installing the Version 6.0 b045 software updating the Audio Driver and updating to XP Service Pack 3. Additionally, improper wiring could cause the cooling fan to not operate properly. This could present itself as a lockup within approximately 20 minute of initial operation. Installation of the items will help prevent the occurrence of unexpected lockups which could result in the loss of the display information during monitoring and could lead to serious consequences during surgical monitoring.

PRODUCT
Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, REF 141491. The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemented use in patients with the following indications: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved, correction of valgus, varus or posttraumatic deformity, correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure, Recall # Z-1061-2009
MANUFACTURER: Biomet, Inc., Warsaw , IN , by letter dated February 13, 2009. Firm initiated recall is ongoing.
REASON: A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert.

PRODUCT: CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes, Recall # Z-1064-2009
MANUFACTURER: Abbott Laboratories, Santa Clara , CA , by letter on November 17, 2008. Firm initiated recall is ongoing.
REASON: Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.

PRODUCT:
a) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module; GMMI No. 04998618001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, Recall # Z-1065-2009;
b) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module; GMMI No. 04998669001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, Recall # Z-1066-2009;
c) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular D Module; GMMI No. 03284522001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, Recall # Z-1067-2009;
d) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module; GMMI No. 03284549001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, Recall # Z-1068-2009
MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis , IN , by letter dated November 12, 2008. Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki , Japan . Firm initiated recall is ongoing.
REASON: If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results.

PRODUCT
a) Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, M0045663ST0, M0045665ST0, M0045667ST0, M0045670ST0, M0045672ST0, M0045675ST0, M0045676ST0, M0045690ST0, M0045890ST0, M0045748ST0 and M0045749ST0. Product is intended for use to facilitate the intracardiac placement of interventional devices, Recall # Z-1071-2009;
b) Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, M00456620, M00456630, M00456650, M00456700, M00456710 and M00456760. Product is intended for use to facilitate the percutaneous introduction of various types of cardiovascular catheters into either the right or left side of the heart. The sheath may be exchanged and used for left sided placement, after transseptal puncture has first been obtained by another sheath, Recall # Z-1072-2009
MANUFACTURER: Boston Scientific, Corp., San Jose , CA , by letters on December 24, 2008 and January 27, 2009. Firm initiated recall is ongoing.
REASON: The marker band may detach from the sheath and a clinical failure could result in an embolism.

PRODUCT:
a) Healthcare Infinia Hawkeye(R), Model numbers: H2508PY H3000WN H3000WR H3000WW H3000WY H3000WZ H3000YM H3000YS Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1094-2009;
b) GE Healthcare Infinia Hawkeye(R) 4, Model numbers: H3000WC H3000WD Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1095-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha , WI , by letter dated April, 2008. Manufacturer: GE Medical System, Tirat Hacarmel , Israel . Firm initiated recall is ongoing.
REASON: There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head.

PRODUCT:
a) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00200W, 16F x 1.2cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1096-2009;
b) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00201W, 16F x 1.7cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1097-2009;
c) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00202W, 16F x 2.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1098-2009;
d) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00203W, 20F x 1.2cm, 10cc. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1099-2009;
e) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00204W, 20F x 1.7cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1100-2009;
f) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00205W, 20F x 2.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1101-2009;
g) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00206W, 20F x 3.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1102-2009;
h) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00207W, 20F x 4.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1103-2009;
i) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00210, 16F x 2.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1104-2009;
j) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00212W, 20F x 1.7cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1105-2009;
k) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00213W, 20F x 2.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1106-2009;
l) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00214W, 20F x 3.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1107-2009;
m) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1108-2009;
n) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00216W, 24F x 1.7cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1109-2009;
o ) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00217W, 24F x 2.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1110-2009;
p) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00218W, 24F x 3.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1111-2009;
q ) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00219W, 24F x 4.4cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1112-2009;
r) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00221W, 18F x 1.2cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1113-2009;
s) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00222W, 18F x 1.7cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1114-2009;
t) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00223W, 18F x 2.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1115-2009;
u) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00224W, 18F x 3.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1116-2009;
v) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00225W, 18F x 4.4cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, Recall # Z-1117-2009
MANUFACTURER: Recalling Firm: C R Bard, Inc., Salt Lake City , UT , by letter on January 7, 2009. Manufacturer: Bard Puerto Rico , Las Piedras, PR. Firm initiated recall is ongoing.
REASON: Out of specification replacement gastrostomy device was distributed.

PRODUCT:
a) GE Healthcare, Infinia, Model Numbers: ASM000886 ASM001391 ASM001333 ASM001465 ASM001473 ASM001620 ASM500016 H3000WM H3000WT H3000WY and SYS000041. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1119-2009;
b) GE Healthcare, Hawkeye for Infinia, Model Numbers: H3000WR, H3000WW, H3000WZ, H3000YM and H3000YS. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1120-2009;
c) GE Healthcare, Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1121-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha , WI , by letter dated April 2008. Manufacturer: GE Medical System, Tirat Hacarmel , Israel . Firm initiated recall is ongoing.
REASON: The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebellum, which may lead to the potential for misdiagnosis.

PRODUCT: ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents, Recall # Z-1170-2009
MANUFACTURER: Cardinal Health 303 dba Cardinal Health, San Diego , CA , by letter, dated December 19, 2008. Firm initiated recall is ongoing.
REASON: The recall was initiated as a result of a potential for out of specification flow rates. The product may not consistently meet the labeled flow rate range of +/- 15%.

PRODUCT: Internal Sterilizable Paddles and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors. Internal Defibrillation Handles without discharge control: Part Numbers 800441-03 thru 800441-06 Internal Defibrillation Electrodes (threaded end): Part Numbers: 802154-10 thru 802154-19, Recall # Z-1171-2009
MANUFACTURER: Physio Control, Inc., Redmond , WA , by letters, dated February 2, 2009. Firm initiated recall is ongoing.
REASON: Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.

PRODUCT: Integra Bilayer Matrix Wound Dressing, 8 “ x 10” (20 cm x 25 cm); Non-pyrogenic, Do not Re-sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810, Recall # Z-1174-2009
MANUFACTURER: Integra LifeSciences, Corp., Plainsboro , NJ , by letters dated March 10, 2009. Firm initiated recall is ongoing.
REASON: Integra became aware of the potential of open seals in the foil pouch of the wound dressings.

PRODUCT:
a) Pilling(R) Coronary Scissors, 25Deg 7", Catalog numbers: 352164, Recall # Z-1175-2009;
b) Pilling(R) Coronary Scissors, 45Deg 7", Catalog numbers: 352165, Recall # Z-1176-2009;
c) Pilling(R) Coronary Scissors, 60Deg 7", Catalog numbers: 352166, Recall # Z-1177-2009;
d) Pilling(R) Coronary Scissors, 90Deg 7", Catalog numbers: 352167, Recall # Z-1178-2009;
e) Pilling(R) Coronary Scissors, 120Deg 7", Catalog numbers: 352168, Recall # Z-1179-2009;
f) Beall(R) Circumflex Artery Scissors, Catalog numbers: 352169, Recall # Z-1180-2009;
g) Pilling(R) Coronary Scissors, 120Deg w/bar, Catalog numbers: and 352178, Recall # Z-1181-2009
MANUFACTURER: Recalling Firm: Teleflex Medical, Durham , NC , by letter dated March 3, 2009. Manufacturer: Teleflex Medical, Research Triangle Park , NC . Firm initiated recall is ongoing.
REASON: The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries.

PRODUCT: diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis, Recall # Z-1204-2009
MANUFACTURER: DiaDexus, Inc., South San Francisco , CA , by telephone and letter on November 4, 2008. Firm initiated recall is ongoing.
REASON: Storage equipment failure at distributor site due to Hurricane Ike caused product to experience a temperature variation and go out of range. The integrity of the product could not be assured.

CLASS III

PRODUCT: ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease, Recall # Z-1044-2009
MANUFACTURER: Immuno Concepts, Inc., Sacramento , CA , by letter, e-mail and telephone December 4, 2008. Firm initiated recall is ongoing.
REASON: Samples can occasionally run out of the wells and cross contaminate adjacent wells.

PRODUCT: Medtronic RV Lead Integrity Alert, Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators, Recall # Z-1172-2009
MANUFACTURER: Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Mounds View, MN, by letters dated November 2008, and December 10, 2008. Manufacturer: Medtronic, Inc., Minneapolis , MN . Firm initiated recall is ongoing.
REASON: Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo" defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 8, 2009:

CLASS II

PRODUCT: Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. The spacer product is intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried by the attending physician, Recall # Z-1020-2009
MANUFACTURER: Theragenics Corp., Buford GA , by telephone on December 8, 2008 and letter dated January 13, 2009. Firm initiated recall is ongoing.
REASON: Some pouches were found to have weak seals potentially compromising sterility.

PRODUCT: GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other network devices in Monitor Network. Network connection consists of hardwire network and/or wireless LAN (WLAN) connection. The iCentral can be used for remote monitor management, storage, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other network devices. The Dates-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is to be used by qualified personnel only, Recall # Z-1039-2009
MANUFACTURER: Recalling Firm: GE Healthcare, Wauwatosa , WI , by letter dated January 26, 2009. Manufacturer: GE Healthcare Finland Oy, Helsinki , Finland . Firm initiated recall is ongoing.
REASON: GE Healthcare is providing information about two issues associated with iCentral L-NETO5 and L-NETC05 v4.3, 4.4, 4.5 and 5.0 when used in combination with Dash 2000, 3000, 4000 and 5000; Solar 7000, 8000, 8000M and 8000i; Eagle 3000 and 4000 and ApexPro. The iCentral does not provide audio or visual alarming for the following: A FIB, VT> and PVC(1) alarms when used with ApexPro and VT>2 and PVC (1) when used when used with Solar, DASH or Eagle (Cardiac Package software). The concern is that this issue may lead to delay in treatment.

PRODUCT: a) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile; REF 32-8105-027-04. The device is utilized for a total elbow arthroplasty surgical procedure, Recall # Z-1053-2009;
b) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch length, sterile; REF 32-8105-027-06. The device is utilized for a total elbow arthroplasty surgical procedure. Recall # Z-1054-2009;
c) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, 3 inch length, sterile; REF 32-8105-043-01. The device is utilized for a total elbow arthroplasty surgical procedure, Recall # Z-1055-2009;
d) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, 3 inch length, sterile; REF 32-8105-043-02. The device is utilized for a total elbow arthroplasty surgical procedure, Recall # Z-1056-2009;
e) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, long, sterile; REF 32-8105-093-01. The device is utilized for a total elbow arthroplasty surgical procedure, Recall # Z-1057-2009;
f) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, long, sterile; REF 32-8105-093-02. The device is utilized for a total elbow arthroplasty surgical procedure, Recall # Z-1058-2009
MANUFACTURER: Zimmer, Inc., Warsaw , IN , by letter dated January 30, 2009. Firm initiated recall is ongoing.
REASON: The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.

PRODUCT: Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruction of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present. a) Part Number SC1439-0600; b) Part number SC1439-0700; c) Part number SC1439-0800; d) Part number SC1439-0900; e) Part number SC1439-1000; f) Part number SC1439-1125; g) Part number SC1439-1250; h) Part number SC1439-1375; i) Part number SC1439; j) Part number SC1439-1625; k) Part number SC1439-1750, Recall # Z-1073-2009
MANUFACTURER: Stelkast Co., Memurray , PA , by telephone on October 31, 2008. Firm initiated recall is ongoing.
REASON: A possible breach of the sterile barrier packaging (Tyvek pouch).

PRODUCT: Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use, Recall # Z-1089-2009
MANUFACTURER: Zeus Scientific, Inc., Somerville , NJ , by letters on August 19, 2008. Firm initiated recall is ongoing.
REASON: The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read

PRODUCT: ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K, Recall # Z-1122-2009
MANUFACTURER: Recalling Firm: Trumpf Medical Systems, Inc., Charleston , SC , by letter starting February 27, 2009. Manufacturer: Trumpf Kreuzer, Puchheim , Germany . Firm initiated recall is ongoing.
REASON: Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.

PRODUCT: a) Stryker Electric Stretcher with the Quick Drop CPR option, Model 1050, Recall # Z-1230-2009; b) Stryker Electric Stretcher with the Quick Drop CPR option, Model 1550, Recall # Z-1231-2009
MANUFACTURER: Stryker Medical Div. of Stryker Corp., Portage , MI , by letter dated February 27, 2009. Firm initiated recall is ongoing.
REASON: The head section backrest (fowler) may not raise up, or , if up, may drop suddenly due to wearing out of the actuator threads on the fowler.

CLASS III

PRODUCT: BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose, Recall # Z-1043-2009
MANUFACTURER: Lexamed, Toledo , OH , by telephone on January 13, 2009 and letter on January 14, 2009. Firm initiated recall is ongoing.
REASON: Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.

PRODUCT: RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system; Kit catalog number: 7096-09 and kit catalog number: 7696-09, Recall # Z-1045-2009
MANUFACTURER: Immuno Concepts, Inc., Sacramento , CA , by telephone, e-mails and letters on December 1l, 2008. Firm initiated recall is ongoing.
REASON: In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 1, 2009:

CLASS I

PRODUCT:
1) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782L. Sizes: 3 CM in length, REF (240) 27782L. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized. Recall # Z-1124-2009;
2) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782K. Sizes: 5.5CM in length, REF (240) 27782K. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1125-2009;
3) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782J. Sizes: 4.5 CM in length, REF (240) 27782J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall Z-1126-2009;
4) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782H. Sizes: 11 CM in length, REF (240) 27782H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1127-2009;
5) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782G. Sizes 10cm in length, REF (240) 27782G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1128-2009;
6) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782F. Sizes: 9 CM in length, REF (240) 27782F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1129-2009;
7) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782E. Sizes: 8 CM in length, REF (240) 27782E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1130-2009;
8) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782D. Sizes: 7 CM in length, REF (240) 27782D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1131-2209;
9) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Sizes: 6 CM in length, REF (240) 27782C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1132-2009;
10) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782B. Sizes: 5 CM in length, REF (240) 27782B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1133-2009;
11) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A. Sizes: 4 CM in length, REF (240) 27782 a. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1134-2009;
12) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27708A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1135-2009;
13) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27708B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1136-2009;
14) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27708C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1137-2009;
15) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27708D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z1138-2009;
16) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1139-2009;
17) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1140-2009;
18) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9CM, Ref 27708G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1141-2009;
19) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1142-2009;
20) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1143-2009;
21) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27802A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1144-2009;
22) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27802B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1145-2009;
23) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27802C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1146-2009;
24) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1147-2009;
25) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27802E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1148-2009;
26) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27802F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1149-2009;
27) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9 CM, Ref 27802G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1150-2009;
28) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1151-2009;
29) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27802J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, Recall # Z-1152-2009
MANUFACTURER: Medtronic Neurosurgery, Goleta , CA , by letter on February 13, 2009. Firm initiated recall is ongoing.
REASON: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.

PRODUCT:
a) Tri-State Centurion Chest Tube Insertion Tray, sterile, 6 per case; Reorder CHT620, Recall # Z-1157-2009;
b) Tri-State Centurion Chest Tube Insertion Tray (Dentry/Bardmoor), sterile, 6 per case; Reorder CHT505, Recall # Z-1158-2009;
c) Tri-State Centurion PICC Line Tray, sterile, 10 per case; Reorder CVI2370, Recall # Z-1159-2009;
d) Tri-State Centurion PICC Insertion Tray, sterile, 15 per case; Reorder CVI2415A, Recall # Z-1160-2009;
e) Tri-State Centurion PICC/CVC Insertion Tray, sterile, 15 per case, Reorder CVI2490, Recall # Z-1161-2009;
f) Lee Medical Neonatal/Ped PICC Insertion Tray, sterile, 15 per case; Reorder CVI1025, Recall # Z-1162-2009;
g) Tri-State Centurion Port Access Kit, sterile, 20 per case; Reorder KNV35, Recall # Z-1163-2009;
h) Tri-State Centurion Port Access Tray, sterile, 20 per case; Reorder DT4825, Recall # Z-1164-2009;
i) Tri-State Centurion Port Access Tray, sterile, 20 per case; Reorder DT5245, Recall # Z-1165-2009;
j) Tri-State Centurion Port Access Tray, sterile, 20 per case; Reorder KNV75, Recall # Z-1166-2009;
k) Tri-State Centurion Implanted Access Port Tray, sterile, 16 per case; Reorder DT7105, Recall # Z-1167-2009;
l) Tri-State Centurion Sutureless Multi-Lumen CVC Insertion Kit, sterile, 5 per case, Reorder ECVC175, Recall # Z-1168-2009;
m) Tri-State Centurion Umbilical Vessel Tray without catheter, sterile, 5 per tray; reorder UVT 170, Recall # Z-1169-2009
MANUFACTURER: Recalling Firm: Tri-State Hospital Supply Corp., Howell , MI , by letter dated January 14, 2009. Tri-State Hospital Supply Corp., Salisbury , NC . Firm initiated recall is ongoing.
REASON: Lack of assurance of sterility, as the package seals may be inadequate.

CLASS II

PRODUCT: Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride, R ecall # Z-1009-2009
MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis , IN , by letter dated November 17, 2008. Manufacturer: Roche Instrument Center AG, Rotkreuz , Switzerland
REASON: Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. Without the glue, the cap can become loose or misaligned. The effect of these faulty valves is that they may not open or close properly which can disturb the fluid transportation within the ISE module resulting in problems with ISE calibration, controls and/or sample results. Inaccurate and unflagged results may be generated and a wrong diagnosis due to incorrect results cannot be excluded.

PRODUCT: QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035. Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. Indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications, Recall # Z-1040-2009
MANUFACTURER: Recalling Firm: Leica Microsystems, Inc., Bannockburn , IL , by letters dated November 6, 2008. Manufacturer: Vision Biosystems, Mount Waverley , Australia . Firm initiated recall is ongoing.
REASON: A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.

PRODUCT: Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600. Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c, Recall # Z-1041-2009
MANUFACTURER: Bio-Rad Laboratories, Inc., Hercules, CA, by letter, fax and telephone on October 17, 2008. Firm initiated recall is ongoing.
REASON: Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.

PRODUCT: DiaSorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use, Recall # Z-1042-2009
MANUFACTURER: Recalling Firm: DiaSorin, Inc., Stillwater , MN , by visit on/about January 5, 2009. Manufacturer: Stratec Biomedical Systems AG, Birkenfeld , Germany . Firm initiated recall is ongoing.
REASON: DiaSorin determined that there was a potential for a short to occur in a residual starter pump electrical cable in the LIAISON ® Analyzer.

PRODUCT: Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Intended to be used with impaction Drill. Drill is used for surgical procedures involving precision drilling and cutting of bone and hard tissue. The bur guard covers the nose of the handpiece and the shaft of the cutting accessory to prevent exposure to heat and moving parts, as well as minimize bur whip and handpiece vibration. Recall # Z-1052-20098
MANUFACTURER: Stryker Instruments, Div. of Stryker Corp., Portage , MI , by letter dated January 27, 2009. Firm initiated recall is ongoing.
REASON: Bur guards were distributed without an expiration date, and if they are used after they have expired it could result in the patient or operating room staff experiencing a burn or laceration.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 25, 2009:

CLASS II

PRODUCT: PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. PROSTIVA RF Therapy Kit 8929, Sterilized using ethylene oxide. Indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 cm3 and 50 cm3, Recall # Z-1060-2009
MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter on August 6, 2008. Manufacturer: Medtronic Puerto Rico, Inc., Villalba, PR. Firm initiated recall is ongoing.
REASON: Reported incidents of needle retraction failure when using the PROSTIVA RF Model 8929 Hand Piece.

PRODUCT: OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, Recall # Z-1070-2009
MANUFACTURER: LifeScan Inc., Milpitas, CA, by letters dated November 24, 2008. Firm initiated recall is ongoing.
REASON: Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.

PRODUCT: a) Magic3 (Intermittent Catheter), Sterile, Uncoated 6 French Pediatric Length REF 52306. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1074-2009;
b) Magic3 (Intermittent Catheter), Sterile, Uncoated 8 French Pediatric Length REF 52308. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1075-2009;
c) Magic3 (Intermittent Catheter), Sterile, Uncoated 10 French Pediatric Length REF 52310. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1076-2009;
d) Magic3 (Intermittent Catheter), Sterile. Hydrophilic 6 French Pediatric Length REF 52606. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1077-2009;
e) Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Male Length REF 53310. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1078-2009;
f) Magic3 (Intermittent Catheter), Sterile. Hydrophilic 8 French Pediatric Length REF 52608. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1079-2009;
g) Magic3 (Intermittent Catheter), Sterile. Hydrophilic 10 French Pediatric Length REF 52610. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1080-2009;
h) Magic3 (Intermittent Catheter), Sterile. Hydrophilic 12 French Male Length REF 53612. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1081-2009;
i) Magic3 (Intermittent Catheter), Sterile. Hydrophilic 14 French Male Length REF 53614. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1082-2009;
j) Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1083-2009;
k) HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs REF#63612SPL, Sterile R. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1084-2009;
l) HydroSil (Intermittent Catheter), Hydrophilic 14 French Male Length Sample Packs REF#63614SPL, Sterile R. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1085-2009;
m) HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1086-2009;
n) HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1087-2009
MANUFACTURER: Rochester Medical Corp., Stewartville, MN, by telephone, in-person visit, e-mail or letter dated January 14, 2009. Firm initiated recall is ongoing.
REASON: Catheter packages in which the catheter was caught in the package seal during the packaging process.

PRODUCT: Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine, Recall # Z-1088-2009
MANUFACTURER: Biosite, Inc., San Diego, CA, by letters dated November 5, 2008. Firm initiated recall is ongoing.
REASON: The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market surveillance thresholds for customer complaints in the field. In addition, the firm has been able to reproduce false positive results reported by customers and as a result we are conducting this voluntary recall.

PRODUCT: BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage, Recall # Z-1090-2009
MANUFACTURER: Recalling Firm: Bd Diagnostic Systems Tripath, Durham, NC, by telephone on September 26, 2008 and by letter on September 29, 2008. Manufacturer: Bd Diagnostics, Burlington, NC. Firm initiated recall is ongoing.
REASON: Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially resulting in mismatched patient results.

CLASS III

PRODUCT: Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, and an over the wire retractable sheath delivery system, Recall # Z-0642-2009
MANUFACTURER: Medtronic Cardiovascular, Santa Rosa, CA, by letter on November 21, 2008. Firm initiated recall is ongoing.
REASON: Mislabeled: Product may contain wrong instructions for use – may contain International IFU instead of the correct US (for Biliary indication use only)

PRODUCT: Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties. Recall # Z-1008-2009
MANUFACTURER: Recalling Firm: Remel, Inc., Lenexa, KS, by letters dated October 7, 2008. Manufacturer: Oxoid, Ltd., Basingstoke, UK. Firm initiated recall is complete.
REASON: Control and test wells are reversed on some of the reaction cards.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 18, 2009:

CLASS II

PRODUCT: a) Light Diagnostics SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121, For in Vitro Diagnostic Use.. The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet, Recall # Z-0953-2009;
b) Light Diagnostics Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is a component in the Kit Catalog #3121 Simulfluor Flu A / Flu B DFA kit, Recall # Z-0954-2009
MANUFACTURER: Millipore, Corp., Temecula, CA, by telephone and letter on November 24, 2008. Firm initiated recall is ongoing.
REASON: Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use may lead to a potential misdiagnosis of influenza B.

PRODUCT: Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile; REF 5020-06-001. Component used to augment uni- and bi- compartmental defects and is manufactured from Ti-6A1-4V Alloy, Recall # Z-0996-2009
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated January 29, 2009 and email on February 19, 2009. Manufacturer: Zimmer Austin, Inc., Austin, TX. Firm initiated recall is ongoing.
REASON: The package contains 11 mm screws instead of the specified 6 mm screws.

PRODUCT:
a) Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile; REF 3511. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon, Recall # Recall # Z-1010-2009;
b) Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 30 mm, 11.5 mm, sterile; REF 3513. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon, Recall # Z-1011-2009;
c) Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm, 5.5 Fr, 20 mm, sterile; REF 3515. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon, Recall # Z-1012-2009
MANUFACTURER: Boston Scientific, Corp., Spencer, IN, by letter dated January 8, 2009. Firm initiated recall is ongoing.
REASON: The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.

PRODUCT:
a) Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1014-2009;
b) Medtronic TSRH Spinal System, 3Dx Splined Connector, Small; REF 8351510. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1015-2009;
c) Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; REF 8351511. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1016-2009;
d) Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; REF 8351512. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions. Recall # Z-1017-2009
MANUFACTURER: Recalling Firm: Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK, Warsaw, IN, by letters dated January 9, 2009. Manufacturer: Medtronic Sofamor Danek USA Inc., Memphis, TN. Firm initiated recall is ongoing.
REASON: The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.

PRODUCT:
a) Stryker Cordless Driver 3 Handpiece; REF 4300. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue. Recall # Z-1021-2009;
b) Stryker Rotary Handpiece, Single Trigger, for use with Stryker System 6; REF 6203. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue. Recall # Z-1022-2009;
c) Stryker Rotary Handpiece, Single Trigger, for use with Stryker System 6; REF 6203-000-000S1. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue. Recall # Z-1023-2009;
d) Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6; REF 6205. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue. Recall # Z-1024-2009;
e) Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6; REF 6205-000-000S1. The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue. Recall # Z-1025-2009;
f) Stryker Reciprocating Saw, For use with Stryker System 6; REF 6206. Product is a linear cutting device used for cutting bone and bone related tissue. Recall # Z-1026-2009;
g) Stryker Sternum Saw, for use with Stryker System 6; REF 6207. The product is a linear cutting device used for cutting bone and bone related tissue including the sternum. Recall # Z-1027-2009;
h) Stryker Sagittal Saw, for use with Stryker System 6; REF 6208. Note: The product label declares the product to be a handpiece. The product is an oscillating cutting device used for cutting bone and bone related tissue. Recall # Z-1028-2009;
i) Stryker Sagittal Saw, for use with Stryker System 6; REF 6208-000-000S4. The product is an oscillating cutting device used for cutting bone and bone related tissue. Recall # Z-1029-2009;
j) Stryker Precision Oscillating Tip Saw, for use with Stryker System 6; REF 6209. The product is an oscillating cutting device used for cutting bone and bone related tissue. Recall # Z-1030-2009
MANUFACTURER: Stryker Instruments Division of Stryker Corp., Portage, MI, by letter dated October 10, 2008. Firm initiated recall is ongoing.
REASON: The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage.

PRODUCT:
a) Integra Mosaik Putty, 15cc, Catalog # PTY10256. Recall # Z-1034-2009;
b) Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021. Recall # Z-1035-2009
MANUFACTURER: Integra LifeSciences, Corp., Plainsboro, NJ, by letters on January 21, 2009. Firm initiated recall is ongoing.
REASON: Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.
PRODUCT: PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. PROSTIVA RF Therapy Kit 8929, Sterilized using ethylene oxide. Indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 cm3 and 50 cm3. Recall # Z-1060-2009
MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter on August 6, 2008. Manufacturer: Medtronic Puerto Rico, Inc., Villalba, PR, Firm initiated recall is ongoing.
REASON: Reported incidents of needle retraction failure.

PRODUCT: Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set; Reorder # RT-160-500. Pointe Scientific Glucose Oxidase Reagent; Catalog # 2-G7519-L, 7-G7519-100, 7-G7519-200, 7-G7519-1000, 8-G7519-100, and 12-RT-160-500. For the quantitative determination of Glucose in human serum. For in vitro diagnostic use only. Recall # Z-1091-2009
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter dated November 3, 2008. Firm initiated recall is ongoing.
REASON: The product is unable to maintain the specification for linearity through the shelf life of the product.

PRODUCT :
a) GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System; The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications. Recall # Z-1092-2009;
b) Innova 4100 / 4100 IQ, The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications. Recall # Z-1093-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by on site visits from March 6, 2008 – December 19, 2008. Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON: GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.

CLASS III
PRODUCT: AcuSnare Polypectomy Soft Snare, Order number SASM-1, packed 5 boxes, 10 units per box. This device is used with an electrosurgical unit for endoscopic polypectomy. Recall # Z-1059-2009
MANUFACTURER: Cook Endoscopy, Winston Salem, NC, by letter on/about January 21, 2009. Firm initiated recall is ongoing.
REASON: The snare head is hexagonal but the handle and packaging indicate an oval reorder number.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 4, 2009:

CLASS II

PRODUCT:
a) Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body. Recall # Z-0522-2009;
b) Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System. Product also marketed as Philips 4000 New Standard, Philips 4000 System and Multibeam System. According to the firm, these units have the same user manual as the HDI4000 system. The different names are used internally as a description for the different configurations of model HDI 4000. Over the product lifecycle, the product configuration changed as follows: MULTIBEAM SYSTEM : This was the original HDI 4000 system branded with the former company name 'ATL'; PHILIPS 4000 SYSTEM :This configuration changed the legacy 'ATL' brand / colors to the 'Philips' brand / colors; PHILIPS 4000 NEW STANDARD: This Philips brand configuration eliminated hardware that supported the 'CV'. The CV option was initially standard, but later became optional depending on customer preference. The product ID label is the same for both PHILIPS 4000 SYSTEM and PHILIPS 4000 NEW STANDARD. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body. Recall # Z-0523-2009
MANUFACTURER: Recalling Firm: Philips Medical Systems, Andover MA , by letter dated July 2008. Manufacturer: Philips Ultrasound, Inc., Bothell , WA . Firm initiated recall is ongoing.
REASON: The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values.

PRODUCT:
1) King Systems, Datex-Ohmeda, Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # CP-05204. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0675-2009;
2) King Systems, Datex-Ohmeda, Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # CP-05207. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0676-2009;
3) King Systems, Datex-Ohmeda, Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # CP-05208. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0677-2009;
4) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # F90715. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0678-2009;
5) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # F90689. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0679-2009;
6) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90727. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0680-2009;
7) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # CF070-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0681-2009;
8) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # CF070-06. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0682-2009;
9) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # CF070-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0683-2009;
10) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # AL-DF370-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0684-2009;
11) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # CF0110-06-54. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0685-2009;
12) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # CF070-23021. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0686-2009;
13) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # CF470-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0687-2009;
14) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF170-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0688-2009;
15) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # CF370-06Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0689-2009;
16) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # CF0110-230. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0690-2009;
17) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # CF470-06Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0691-2009;
18) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # CF370-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0692-2009;
19) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # CF470-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0693-2009;
20) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # CF470-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0694-2009;
21) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF070-6114. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0695-2009;
22) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF070-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0696-2009;
23) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF070-17621. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0697-2009;
24) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF070-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0698-2009;
25) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF370-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0699-2009;
26) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF270-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall Z-0700-2009;
27) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF270-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0701-2009;
28) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF0110-618. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0702-2009;
29) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF370-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0703-2009;
30) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF370-26Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0704-2009;
31) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF375-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0705-2009;
32) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF370-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0706-2009;
33) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF370-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0707-2009;
34) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF370-611Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0708-2009;
35) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF375V-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0709-2009;
36) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF375-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0710-2009;
37) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF375-60Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0711-2009;
38) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF370-6133Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0712-2009;
39) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF375-618Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0713-2009;
40) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF375-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0714-2009;
41) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF375-6113Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0715-2009;
42) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF375-6021Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0716-2009;
43) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF375-6133Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0717-2009;
44) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF375-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0718-2009;
45) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF375V-618Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0719-2009;
46) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF375-17621Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0720-2009;
47) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF470-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0721-2009;
48) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF376R-60XP. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0722-2009;
49) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF376-608Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0723-2009;
50) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF375V-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0724-2009;
51) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF376-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0725-2009;
52) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF376-618Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0726-2009;
53) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF376R-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0727-2009;
54) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF376R-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0728-2009;
55) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF470-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0729-2009;
56) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF470-6113. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0730-2009;
57) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF475-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0731-2009;
58) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF470-6139X. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Z-0732-2009;
59) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF470-60Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0733-2009;
60) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF376R-6133Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0734-2009;
61) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF470-618Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0735-2009;
62) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF470-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0736-2009;
63) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF470-6127Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0737-2009;
64) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF470-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0738-2009;
65) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF475-618. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0739-2009;
66) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF475-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0740-2009;
67) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF475S-61P. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0741-2009;
68) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF475-618Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0742-2009;
69) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF475-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0743-2009
70) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF475-60Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0744-2009;
71) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF475V-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0745-2009;
72) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF475-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0746-2009;
73) King Systems Universal Flex2 Breathing Circuit, 40 per case; REF # DF2110-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0747-2009;
74) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF476-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0748-2009;
75) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF476V-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0749-2009;
76) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF476-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0750-2009;
77) King Systems Universal Flex2 Breathing Circuit, 40 per case; REF # DF3110-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0751-2009;
78) King Systems Universal Flex2 Breathing Circuit, 40 per case; REF # DF3110-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0752-2009;
79) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF3110-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall Z-0753-2009;
80) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF2110-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0754-2009;
81) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF3115-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0755-2009;
82) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF3110-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0756-2009;
83) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF3116S-608Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0757-2009;
84) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF3116-6021Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0758-2009;
85) King Systems Universal Flex2 Breathing Circuit, 40 per case; REF # DF4110-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0759-2009;
86) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DNCF470-06. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0760-2009;
87) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF4115-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0761-2009;
88) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF #
DF4110-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0762-2009;
89) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF4116-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0763-2009;
90) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF4115-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0764-2009;
91) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DFB1110-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0765-2009;
92) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF4116R-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0766-2009;
93) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DFP170-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0767-2009;
94) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DFP170-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall #Z-0768-2009;
95) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DFP270-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0769-2009;
96) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DFP173-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0770-2009;
97) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DFR170-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0771-2009;
98) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DFP2110-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0772-2009;
99) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DFY170-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0773-2009;
100) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DFY170-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0774-2009;
101) King Systems Universal Flex2 Breathing Circuit, 40 per case; REF # DF3116-6021. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0775-2009;
102) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DNCF370-0621. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0776-2009;
103) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DNCF3756-0621Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0777-2009;
104) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DNCF375V-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0778-2009;
105) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DNCF376-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0779-2009;
106) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DNCF375V-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0780-2009;
107) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DNCF470-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0781-2009;
108) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DNCF376R-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0782-2009;
109) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # NCF475-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0783-2009;
110) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DSNCF070-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0784-2009;
111) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # SNDF1110-6131Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0785-2009;
112) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # NDF3110-6131Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0786-2009;
113) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF275V-6121. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0787-2009;
114) King Systems Universal Flex2 Breathing Circuit, Latex Free, 40 per case; REF # DF3115-6154Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0788-2009;
115) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF370-6127Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0789-2009;
116) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF375V-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0790-2009;
117) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF376-6127Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0791-2009;
118) King Systems Universal Flex2 Breathing Circuit, 50 per case; REF # DF475V-61. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0792-2009;
119) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF475V-61Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0793-2009;
120) King Systems Universal Flex2 Breathing Circuit, Latex Free, 50 per case; REF # DF477S-6121Z. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0794-2009;
121) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90698. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0795-2009;
122) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 30 per case; REF # F90701. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0796-2009;
123) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90721. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0797-2009;
124) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case; REF # F90732. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0798-2009;
125) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case; REF # F90736. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0799-2009;
126) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90739. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0800-2009;
127) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90745. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0801-2009;
128) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90751. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0802-2009;
129) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90755. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0803-2009;
130) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90756. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0804-2009;
131) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case; REF # F90757. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0805-2009;
132) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90763. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0806-2009;
133) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90764. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0807-2009;
134) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90767. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0808-2009;
135) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case; REF # F90768. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0809-2009;
136) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case; REF # F90773. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0810-2009;
137) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case; REF # F90778. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0811-2009;
138) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 40 per case; REF # F90780. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0812-2009;
139) King Systems Universal Flex2 Breathing Circuit and Pack Kit, Latex Free, 50 per case; REF # F90781. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0813-2009;
140) King Systems Universal Flex2 Breathing Circuit & Pack Kit, Latex Free, 50 per case; REF # F90787. This breathing circuit is a device intended to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation. Recall # Z-0814-2009;
141) King Systems 37" Universal Flex2 Extension Kit, 50 per case; REF # XF37. Recall # Z-0815-2009;
142) King Systems 72" Universal Flex2 Extension Kit, 50 per case; REF # XF75. Recall # Z-0816-2009
MANUFACTURER: King Systems Corp., Noblesville , IN , by letter on or about July 29, 2008. Firm initiated recall is ongoing.
REASON: The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels.

PRODUCT:
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Model 801763. The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist. Recall # Z-0909-2009;
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Model 801764. (Not distributed within the United States ). The device is indicated for use in the extracorporeal circulation of blood for arterial perfusion and cardiopulmonary bypass procedures by a perfusionist. Recall # Z-0910-2009
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor , MI , by letter on November 7, 2008. Firm initiated recall is ongoing.
REASON: The power manager board may cause a short circuit, resulting in loss of system power, loss of central control monitor or electrical arcing.

PRODUCT: Invacare Storm TDX SP Power Wheelchair with Stability Lock, Model numbers: TDXSP, TDXSP-CG, and TDXSP-MCG To provide mobility to a person restricted to a sitting position. Recall # Z-0930-2009
MANUFACTURER: Invacare Corp., Elyria , OH , by letters on November 27, 2007. Firm initiated recall is ongoing.
REASON: Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may veer to one side or it may rock forward onto its front riggings.

PRODUCT:
Stryker InTouch l.0 Critical Care Bed; Model 2130. The device is intended to be used as an Intensive Care Unit bed. Recall # Z-0940-2009;
b) Stryker InTouch 1.0 Zoom Critical Care Bed; Model 2140. The device is intended to be used as an Intensive Care Unit bed. Recall # Z-0941-2009;
c) Stryker InTouch 1.0 Critical Care Bed (Model 2130) with the Integrated PositionPro mattress (Model 2920) option. The device is intended to be used as an Intensive Care Unit bed. Recall # Z-0942-2009;
d) Stryker InTouch 1.0 Zoom Critical Care Bed (Model 2140) with the Integrated PositionPro mattress (Model 2920) option. The device is intended to be used as an Intensive Care Unit bed. Recall # Z-0943-2009
MANUFACTURER: Recalling Firm: Stryker Medical Div. of Stryker Corp., Portage , MI , by letter dated January 5, 2009. Manufacturer: Stryker Medical Quebec , LP, L'lsletville, Canada Firm initiated recall is ongoing.
REASON: The touch screen on the footboard may display a “tilt over range” error, resulting in a precautionary stop of the bed motions which result in the bed appearing to have locked out some of its bed positioning features. Also, the "hold" button, used to interrupt an intended patient turn on beds with an integrated PositionPro mattress, may only function intermittently, resulting in an inability to hold a patient turn at the desired state.

PRODUCT: Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03. For use in the calibration of the Iron and Magnesium assays. Recall # Z-0950-2009
MANUFACTURER: Recalling Firm: Abbott Laboratories, Inc., South Pasadena , CA , by letter on April 24, 2008. Manufacturer: Microgenics Corp., Fremont, CA. Firm initiated recall is ongoing.
REASON: An incorrect Magnesium calibrator 2 value (CAL 2) was provided for Clinical Chemistry Iron/Magnesium Calibrator lot number 54187M200. Use of the incorrect Magnesium CAL 2 value causes quality control and patient magnesium results to be reduced by as much as 17.24% above 0.8mEq/L (1.0 mg/dL or 0.4 mmol/L).

PRODUCT: ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01. Recall # Z-0951-2009
MANUFACTURER: Recalling Firm: Abbott Laboratories, Inc., Irving , TX , by letters on September 9, 2008. Manufacturer: Inpeco Spa, Segrate , Italy . Firm initiated recall is ongoing.
REASON: ACCELERATOR APS Centrifuge Module being recalled due to potential for micro-cracks to form over time in the metal centrifuge rotor buckets that may cause the centrifuge buckets to disconnect from the rotor in the centrifuge during centrifugation.

PRODUCT: EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the laboratory or at the point of care in hospitals, nursing homes, or other clinical care institutions. The Blood Gas Electrolyte (BGE) test card panel of this device includes sensors for testing Sodium, Potassium, ionized Calcium, pH, pCO2, pO2 and Hematocrit. Recall # Z-0952-2009
MANUFACTURER: Recalling Firm: Epocal, Ottawa , Canada , by visit on October 18, 2008. Manufacturer: Epocal, Inc. Horsham , PA. Firm initiated recall is complete.
REASON: Elevated range of potassium levels

PRODUCT: GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. Recall # Z-0969-2009
MANUFACTURER: G E Healthcare Integrated IT Solutions, Barrington , IL , by letter dated January 12, 2009. Firm initiated recall is ongoing.
REASON: If a user site created a custom default display protocol (DDP) to display the current exam versus the historical exam and the user-defined DDP fails, the system displays the exams using a GE default hanging protocol. This may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars.

PRODUCT: 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. These rechargeable batteries are used to supply power to patient monitoring system's wireless modules and gating/triggering systems' fiber optic modules. Recall # Z-0971-2009
MANUFACTURER: Invivo Corp., Orlando , FL , by letters, dated August 2008. Firm initiated recall is ongoing.
REASON: Battery Failure: The Invivo Lithium Polymer Wireless Module Battery Part Number 9065 and the Lithium Polymer Fiber Optic Module Battery Part Number 9067 is being recalled because the battery, itself, when dropped from 3 feet/1 meter onto a hard surface can produce a flame and then emit smoke. The firms investigation shows that the battery failure does not occur when a module is dropped with a battery inserted and latched in place .

PRODUCT: Stryker Endoscopy brand 3.5 mm Super 90-S SERFAS Energy Suction Probe; Model number: 279-351-300. Recall # Z-0972-2009
MANUFACTURER: Recalling Firm: Stryker Endoscopy, San Jose , CA , by letters on June 20, 2008. Manufacturer: Stryker Endoscopy, Puerto Rico . Firm initiated recall is complete.
REASON: The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area.

PRODUCT: Sterile Field Saline Flush; 0.9% Sodium Chloride Injection, USP; Rx Only; Single Use. This product is used for the flushing of venous access devices and intravenous tubing.
Product codes: E0100 20, 100 92-240 and 100 92-30. Recall # Z-0973-2009
MANUFACTURER: Excelsior Medical Corp., Neptune , NJ , by letter dated January 13, 2009. Firm initiated recall is ongoing.
REASON: Sterility Issue: There is the possibility that the affected lots have pouches that were not sealed properly and could potentially compromise the external sterility of the syringes.

PRODUCT: Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 mesh size, sterile. Item # 0003. Device is used for filling of periodontal defects following conventional curettage and debridement. The device is also indicated for the esthetic repair of bony defects of the alveolar ridge. Recall # Z-0974-2009
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw , IN , by e-mail and letter dated January 22, 2009. Manufacturer: Zimmer Dental, Inc., Carlsbad , CA. Firm initiated recall is ongoing.
REASON: Fragments of the glass vial may be present in some of the packages.

PRODUCT: Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood flow range 5.0 - 8.5 L/min, Sterilized Using Ethylene Oxide, REF 61399402655. Surgical Membrane Oxygenators are intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures. Additionally, the Integral Membrane Oxygenators are intended to cool and warm the blood by means of the integral heat exchange. Recall # Z-0975-2009
MANUFACTURER: Recalling Firm: Medtronic, Inc., Minneapolis , MN , by letter dated October 17, 2008. Manufacturer: Medtronic Cardiovascular Revascularization & Surgical Therap, Brooklyn Park , MN . Firm initiated recall is ongoing.
REASON: Medtronic has identified an issue with the labeling of the I-4500 Silicone Oxygenators (P/N 61399402655). Lot numbers of this oxygenator manufactured between August 2007 and September 2008 have an incorrect "Recommended maximum blood flow range" on the label. The label on the device states a range of 5.0 - 8.5 L/min but should state a range of 5.0 - 6.5 L/min. These oxygenators are acceptable to use at flow rates between 5.0 - 6.5 L/min. In the unlikely event that this device was actually run to 8.5 L/min, the primary patient harm would be high pressure drop across the device, causing hemolysis and potential hematuria. This would be detected via monitors attached to the circuit and the system would be slowed down to an acceptable level. O2 and CO2 transfer could also be impaired. Characterization testing was performed on a device and this testing showed that the device still met the performance requirements for O2 and CO2 transfer when being run at 8.5 L/min.

PRODUCT:
a) Gold Probe 7FR Working Length: 300 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. For Single Use Only. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon. 1) UPN : M00560070; 2) UPN: M00560071. Recall # Z-0977-2009;
b) Gold Probe 10FR Working Length: 300 cm, Probe Tip O.D. 3.2 mm (10Fr), Rx Only. Electrical Connector: Standard. For Single Use Only. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon. 1) UPN: M00560100; 2) for UPN M00560101. Recall # Z-0978-2009;
c) Gold Probe 7FR Working Length: 350 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. Single Use Only. UPN M00560220. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon. Recall # Z-0979-2009
MANUFACTURER: Boston Scientific Corp., Miami , FL , by letter dated December 24, 2008. Firm initiated recall is ongoing.
REASON: Packaging tray may have a crack. Cracks in the tray or damage to the tray of the device may lead to a compromised sterile barrier.

PRODUCT: Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile; REF USH-526-R, GPN REF G49966. The ureteral stent is used for temporary drainage from the ureteropelvic junction to the bladder. Recall # Z-0980-2009
MANUFACTURER: Vance Products Inc., Spencer , IN , by telephone and letter dated November 10, 2008. Firm initiated recall is ongoing.
REASON: "Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device.

PRODUCT:
a) DePuy DNP Anatomic Fracture Repair System, Locking Screw DNP Anatomic; REF DNPALS. The device is used in the treatment of fractures and osteotomies of the distal radius. Recall # Z-0981-2009;
b) DePuy DNP Anatomic Fracture Repair System, JIG DNP Anatomic; REF DNPAJIG. The device is used in the treatment of fractures and osteotomies of the distal radius. Recall # Z-0982-2009;
c) DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Left; REF DNPAL. The device is used in the treatment of fractures and osteotomies of the distal radius. Recall # Z-0983-2009;
d) DePuy DNP Anatomic Fracture Repair System, DNP Anatomic Right; REF DNPAR. The device is used in the treatment of fractures and osteotomies of the distal radius. Recall # Z-0984-2009;
MANUFACTURER: Depuy Orthopaedics, Inc., Warsaw , IN , by letter on December 29, 2008. Firm initiated recall is ongoing.
REASON: The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately.

PRODUCT:
a) Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 30 degrees; REF 00-7806-035-01. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant. Recall # Z-0990-2009;
b) Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees; REF 00-7806-035-02. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant. Recall # Z-0991-2009
MANUFACTURER: Zimmer, Inc., Warsaw , IN , by letter on December 19, 2008. Firm initiated recall is ongoing.
REASON: The c-clip located near the connection end may fracture or fall off during use in surgical procedures.

CLASS III

PRODUCT: Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. The pouch label of the 1.4mm TE Over the Wire (OTW) catheter, Ref # 414-151, L/N# 080417D was incorrectly labeled for size as 0.9mm TE RX, Ref# 410-154, L/N#080417D. The box labels are correct and match the devices in the pouch. The Spectranetics TURBO-BoosterTM guiding catheter is designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions. Recall # Z-0976-2009
MANUFACTURER: Spectranetics Corp., Colorado Springs , CO , by visit December 18, 2008. Firm initiated recall is complete.
REASON: The catheter pouch label was incorrectly labeled with the wrong size.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 25, 2009:
CLASS II
PRODUCT:
a) MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels, 20 panels per box. Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog numbers B1016-100, B1016-101, B1016-102, B1016-105, B1016-107, B1016-108, B1016-109, B1016-119, B1016-120, B1016-121, B1016-122, B1016-126, B1016-127, B1016-128, B1016-129, B1016-131, B1016-132, B1016-61a, B1016-62a, B1016-64a, B1016-65a, B1016-80, B1016-82, B1017-300, B1017-301, B1017-302, B1017-303, B1017-304, B1017-305, B1017-306, B1017-307, B1017-308, B1017-309, B1017-312, B1017-313, B1017-315, B1017-400, B1017-401, B1017-402, B1017-403, B1017-404, B1017-405, B1017-406, B1017-407, J1016-311c, J1016-312c, J1016-611c, J1016-611j, J1016-612b, J1016-612J, J1016-632J, J1016-623m, J1016-631J, J1016-632J, J1016-65c, J1016-66J, J1025-311, J1025-312, J1025-333, and J1025-611. Recall # Z-0540-2009;
b) MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog numbers: B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101. Recall # Z-0541-2009
MANUFACTURER: Siemens Microscan, West Sacramento, CA, by letter on July 31, 2008. Firm initiated recall is ongoing.
REASON: Falsely lowered imipenem MICs may result, leading to major errors in results.

PRODUCT
a) Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S. Recall # Z-0594-2009;
b) Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS. Recall # Z-0595-2009;
c) Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS. Recall # Z-0596-2009
MANUFACTURER: Recalling Firm: Ossur, Reykjavik, Ireland, by telephone on September 26, 2008. Manufacturer: Ossur Engineering, Inc., Albion, MI. Firm initiated recall is ongoing.
REASON: The firm is unable to guarantee the sterility of the affected products.

PRODUCT:
a) ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO. Used for drainage of bile within the biliary system. Recall # Z-0611-2009;
b) ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO. Used for drainage of bile within the biliary system. Recall # Z-0612-2009;
c) ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO. Used for drainage of bile within the biliary system. Recall # Z-0613-2009;
d) ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-14-038, 14F, Sterile EO. Used for drainage of bile within the biliary system. Recall # Z-0614-2009;
MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by telephone or visit beginning November 7, 2008. Firm initiated recall is ongoing.
REASON: Biliary drainage catheter tips may separate from the catheter shaft after placement.

PRODUCT:
a) Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0630-2009;
b) Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813568. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0631-2009;
c) Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0632-2009;
d) Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813570. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0633-2009;
e) Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813571. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0634-2009;
f) Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0635-2009;
g) Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813573. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0636-2009;
h) Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813574. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0637-2009;
i) Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813575. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0638-2009;
j) Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813576. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0639-2009;
k) Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813577. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0640-2009;
l) Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Recall # Z-0641-2009
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated October 16, 2008. Firm initiated recall is ongoing.
REASON: The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.

PRODUCT: Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI. Radiation therapy simulation system. NT with model numbers 1957153, 1957161, 5496992, 5497016, 5496984. Recall Z-0646-2009
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on November 6, 2008. Firm initiated recall is ongoing.
REASON: Excessive wear on drive belts used for Image Intensifier and/or X-ray head drive mechanisms may result in uncontrolled movement, which may cause injury.

PRODUCT: Philips M8000-64100 Table Mount Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and certain options of the IntelliVue Patient Monitors MP5 MPST and MP20/30. Product shipped between 6/03/08 and 9/12/08 as follows: M1013A IntelliVue G1 Gas Module M1019A IntelliVue GS Gas Module M8001A option E22 Quick release mount for IntelliVue MP20 M8002A option E22 Quick release mount for IntelliVue MP30 M8003A IntelliVue MP40 M8004A IntelliVue MPSO M8005A IntelliVue MP60 M8007A IntelliVue MP70 M8105A option E22 IntelliVue MP5 Quick Release Mount M8105AT option E22 IntelliVue MPST Quick Release Mount M8040A option U02 U02 Table top mount kit M8040A option E22 Quick release kit for MP20MP30 The Philips IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. Recall # Z-0817-2009
MANUFACTURER: Recalling Firm: Philips Medical Systems, Andover, MA, by letter dated October 22, 2008. Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Germany. Firm initiated recall is ongoing.
REASON: Table Mounts assembled with incorrect length hardware may fall.

PRODUCT: Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. Recall # Z-0837-2009
MANUFACTURER: Boston Scientific Corp., Fremont, CA, by letter on October 8, 2008. Firm initiated recall is ongoing.
REASON: Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.

PRODUCT: Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0. Recall # Z-0861-2009
MANUFACTURER: Varian Medical Systems oncology Systems, Palo Alto, CA, by letter dated November 21, 2008. Firm initiated recall is ongoing.
REASON: Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and SAD values for Elekta machines, and collimator operating limits for Saturne Machines when the software version is upgraded.

PRODUCT: Stainless Steel Surgical Blades Part number: 4-312B. The product is supplied sterile, individually packaged in boxes containing 100 blades. Recall # Z-0862-2009
MANUFACTURER: Recalling Firm: Miltex, Inc., York, PA, by letter dated November 17, 2008. Manufacturer: Kai Surgical Instrument Co., Ltd., Seki City, Japan. Firm initiated recall is complete.
REASON: Blade may break; Over milling of the blade resulted in tip more narrow than specified.

PRODUCT: Monitor portion of the LifeVest device – specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. Model numbers: WCD3000 and WCD3100. Recall # Z-0883-2009
MANUFACTURER: Zoll Lifecor Corp., Pittsburgh, PA, by letter dated October 21, 2008. Firm initiated recall is ongoing.
REASON: The charging circuit will not shut down properly.

PRODUCT: Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Recall # Z-0887-2009
MANUFACTURER: Regenesis Biomedical, Inc., Scottsdale, AZ, by letter dated September 29, 2008. Firm initiated recall is complete.
REASON: In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio frequency energy. As such, for these few devices, the effectiveness of Provant therapy may be impaired.

PRODUCT: a) Femoral Array, Model number: 0150ARR00001 and b) Tibial Array, Model number: 0150ARR00002. The devices are accessories used with MAKO's Tactile Guidance System (TGS). The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. Recall # Z-0915-2009
MANUFACTURER: Mako Surgical Corp., Davie, FL, by letter dated July 1, 2008. Firm initiated recall is ongoing.
REASON: The product in its current state may fail during use, which would cause the instrument to be in-accurate.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 18, 2009:
CLASS II
PRODUCT: DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter. Recall # Z-0863-2009
MANUFACTURER: Sunrise Medical, Somerset , PA , by telephone on October 27, 2008 and by letter on November 3, 2008. Firm initiated recall is ongoing.
REASON: Improper suction: Regulator knob does not turn properly which can affect the suction level.

PRODUCT: SERVO Ventilator 300A (SV300A). The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside and for intra-hospital transport. It is not intended for transport use in ambulances or in helicopters in the US market. Recall # Z-0872-2009
MANUFACTURER: Recalling Firm: Maquet, Inc., Bridgewater , NJ , by letters on December 22, 2008. Manufacturer: Maquet Critical Care AB , Solna , Sweden . Firm initiated recall is ongoing.
REASON: SERVO Ventilator 300A could cause hyperventilation if the use of the PC or PRVC mode with the Automode function set to "On" in Neonatal and Pediatric patient ranges with small tidal volumes and short set inspiratory rise time.

PRODUCT: a) Zimmer TIV Self Tap Screw, 40 mm. Item number: 48231904000. NOTE: This product is not sold in the United States . The device is used to attach healing plates to long bones for stabilization of fractures during the normal healing process. Devices are individually packaged and sold sterile. Recall # Z-904-2009;
b) Zimmer TIV Self Tap Screw, 42 mm. Item number: 48231904200. NOTE: This product is not sold in the United States . The device is used to attach healing plates to long bones for stabilization of fractures during the normal healing process. Devices are individually packaged and sold sterile. Recall # Z-905-2009
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw , IN , by letter dated December 11, 2008. Manufacturer: Zimmer Manufacturing B.V., Mercedita, PR. Firm initiated recall is ongoing.
REASON: The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.

PRODUCT:
a) Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile; Cat. no./REF 6647, a) inner pouch UPN M00566470 and b) outer carton UPN M00566471. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. Recall # Z-0911-2009;
b) Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile; Cat. no./REF 6649, a) inner pouch UPN M00566490 and b) outer carton UPN M00566491. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. Recall # Z-0912-2009;
c) Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile; Cat. no./REF 6653, a) inner pouch UPN M00566530 and b) outer carton UPN M00566531. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. Recall # Z-0913-2009;
d) Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with pre-filled lidocaine syringe, latex free, sterile; Cat. no./REF 6673, a) inner pouch UPN M00566730 and b) outer carton UPN M00566731. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. Recall # Z-0914-2009
MANUFACTURER: Boston Scientific, Corp., Spencer , IN , by letter dated December 30, 2008.
Firm initiated recall is ongoing.
REASON: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.

PRODUCT:
a) Stryker PainPump, Two Site Infusion Kit with ExFen 2.5", 120 mL Infusion Kit, sterile, 5 per box. Product number: 0500-166-025, REF 500-166-25. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. Recall # Z-0923-2009;
b) Stryker PainPump Two Site Infusion Kit with ExFen 5.0", 120 mL Infusion Kit, sterile, 5 per box. Product number: 0500-166-050, REF 500-166-50. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. Recall # Z-0924-2009;
c) Stryker PainPump Two Site Infusion Set, sterile, 10 per box. Product number: 0500-200-000, REF 500-200. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. Recall # Z-0925-2009
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corp., Portage , MI , by letter dated November 11, 2008. Manufacturer: Medisize Donegal Healthcare, Donegal , Ireland . Firm initiated recall is ongoing.
REASON: There is a potential for the pump to overinfuse.

PRODUCT: Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. REF 575-100, Product Number 0575-100-000. The device is used to deliver controlled amounts of medication and narcotics directly to the intraoperative site for pain management; the pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous and epidural routs. It is also intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management, in which case routes of administration may be intraoperative, perineural or percutaneous. Recall # Z-0926-2009
MANUFACTURER: Recalling Firm: Stryker Instruments, Div. of Stryker Corp., Portage , MI , by letter dated November 12, 2008. Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. Firm initiated recall is ongoing.
REASON: The pump may display an E-4 error message, which causes the pump to stop dispensing the pain medication.

PRODUCT: Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Part Number 8139789. Recall # Z-0927-2009
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord , CA , by letter dated October 23, 2008. Firm initiated recall is ongoing.
REASON: If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption feature, syngo RT Therapist Express systems will display and record a second delivery of a prior beam and not the delivery of the current beam in certain circumstances.

PRODUCT: GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. Recall # Z-0928-2009
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated November 21, 2008. Firm initiated recall is ongoing.
REASON: There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.

PRODUCT: Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix LR can be packed with autograft. Recall # Z-0931-2009
MANUFACTURER: Recalling Firm: Synthes Spine, West Chester , PA , by e-mail on November 20, 2008 and by letters dated November 19, 2008 and January 16, 2009.
Manufacturer: Synthes Gmbh, Oberdorf , Switzerland . Firm initiated recall is complete.
REASON: Screwdriver tip may break off and lodge in the screw head.

PRODUCT: Ergolift 400 Lbs. Floor Lift, model/part numbers ERGOLIFT and ERGOLIFT-2. The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients. Recall # Z-0933-2009
MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle , IL , by Field Safety Notice dated December 8, 2008 and letter dated December 22, 2008. Manufacturer: B.H.M. Medical, Inc., Magog , Canada . Firm initiated recall is ongoing.
REASON: Report of structural failure of the mast during use.

PRODUCT: Posey Connecting Straps and Belts/Locking Cuffs. The device is used to limit the wearer's movement by securing cuffs to a connecting strap or belt. Catalog numbers: 2320, 2330, 2346, 2350, 2351, 2355, 2360, 2208, 2209, 2210, 2211, 2212 and 2213. Recall # Z-0934-2009
MANUFACTURER: J. T. Posey Company, Arcadia , CA , by letter dated August 15, 2008. Firm initiated recall is ongoing.
REASON: A patient may be able to catch the belt on a stationary object and use their body force to tear or break the strap, creating freedom of arm movement.

PRODUCT: Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800.
Recall # Z-0936-2009
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale , NJ , by letters on September 8, 2006. Manufacturer: Stryker Spine, Cestas, Aquitane , France . Firm initiated recall is complete.
REASON: DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.

PRODUCT:
a) VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation. Part Number: 1011759-08. Recall # Z-0938-2009;
b) VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation. Part Number: 1011759-12, 8061961 and Part Number: 1011750-12. Recall # Z-0939-2009
MANUFACTURER: Abbott Vascular-Cardiac Therapies dba Guidant Corp., Temecula , CA , by letter dated November 6, 2008. Firm initiated recall is ongoing.
REASON: The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. The balloon sheath covers the balloon, maintaining the fold configuration and protects the balloon during shipment. It is disposed of during device preparation.
PRODUCT: IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000. IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. The IMPAX Centric Polling Procedure provides a mechanism to ensure that patient demographic and merge/split operations performed on the IMPAX database utilizing the IMPAX Service Tool are captured and applied to the IMPAX CV database, in order to keep patient updates from the IMPAX database synchronized with the IMPAX CV database. Equipment number: 15013696; Equipment number: 10281800; Equipment number: 10262174; Equipment number: 15003839; and Equipment number: 15009724. Recall # Z-0945-2009
MANUFACTURER: AGFA Corp., Greenville , SC , by letter on/about December 24, 2008. Firm initiated recall is ongoing.
REASON: Polling procedure may fail when multiple merge/split is carried out.

PRODUCT: Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System. Recall # Z-0946-2009
MANUFACTURER: St Jude Medical, Inc., Sunnyvale , CA , by letter dated December 4, 2008. Firm initiated recall is ongoing.
REASON: Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit.

PRODUCT: iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3. Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Recall # Z-0948-2009
MANUFACTURER: Philips Healthcare Informatics, Inc., Foster City , CA , by letter on December 29, 2008. Firm initiated recall is ongoing.
REASON: Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.

PRODUCT: Artiste MV Digital Linear Accelerator System equipped with 160 MCL Accessory Holder. Medical charged-particle radiation therapy system. Recall # Z-0949-2009
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord , CA , by letters on December 20, 2008. Firm initiated recall is ongoing.
REASON: The range of tolerance is too high for the accessory holder; therefore, Wedges and other accessories do not latch to the locking mechanism correctly. This issue represents a potential serious injury to a patient or operator.

PRODUCT:
a) HR90K Platinum Series Headpiece Model Number AB-7300-001. The HiRes90K headpiece is used in conjunction with speech processors. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss. Recall # Z-0956-2009;
b) Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech processors. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss. Recall # Z-0957-2009;
c) S-Series Long Range Headpiece a) Model Number AB-5301-00 (beige) and b) AB-5301-10 (brown). The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. Recall # Z-0958-2009;
d) S-Series Short Range Headpiece, a) Model Number MMT-5300-00 (beige) and b) MMT-5300-10 (brown). The headpiece is used in conjunction with speech processors. Recall # Z-0959-2009
MANUFACTURER: Advanced Bionics LLC, Sylmar , CA , by letter on July 24, 2008. Firm initiated recall is ongoing.
REASON: Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cannot measure impedances -Reduction in battery life, primarily for C1 patients with thick flaps.

PRODUCT:
a) PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY (1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer. Recall # Z-0960-2009;
b) PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY (1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer. Recall # Z-0961-2009
MANUFACTURER: Recalling Firm: Smith & Nephew Inc., Memphis , TN , by e-mail on November 21, 2008. Manufacturer: Smith & Nephew Orthopaedics Ag, Rotkreuz , Switzerland . Firm initiated recall is ongoing.
REASON: The product was breaking during use.

PRODUCT: Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile. Unicompartmental knee joint replacement system. Designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. Recall # Z-0962-2009
MANUFACTURER: Recalling Firm: Biomet, Inc., Warsaw , IN , by telephone and letter dated December 19, 2008. Manufacturer: Biomet U.K. , Ltd, Bridgend, South Wales, UK . Firm initiated recall is ongoing.
REASON: Packages labeled as “right” actually contain a “left” component.

PRODUCT:
a) NFix II System 150 mm, Catalog number NX60150-1 spinal fusion surgery. Recall # Z-0963-2009;
b) NFix II System 200 mm, Catalog number NX60200-1. Spinal fusion surgery. Recall # Z-0964-2009;
c) N-Hance System 150 mm, Catalog number NH60150-1. Spinal fusion surgery, Recall # Z-0965-2009;
d) TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S Spinal fusion surgery. Recall # Z-0966-2009;
e) NFlex Stabilization System 200 mm, Catalog number NF60020-1. Spinal fusion surgery. Recall # Z-0967-2009;
f) NFlex Stabilization System 150 mm, Catalog number NF60150-1. Spinal fusion surgery. Recall # Z-0968-2009
MANUFACTURER: Recalling Firm: S ynthes Spine, West Chester , PA , by e-mail on November 18, 2008 and by letters dated November 19, 2008. Manufacturer: Synthes ( USA ), Monument, CO. Firm initiated recall is ongoing.
REASON: The dimensional specifications are incorrect.

PRODUCT: GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. Recall # Z-0970-2009
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington , IL , by letter dated November 10, 2008. Firm initiated recall is ongoing.
REASON: Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 11, 2009:
CLASS II
PRODUCT: Medtronic O-Arm Intraoperative Imaging System, Catalog number: Bl-700-0027, Recall # Z-0624-2009
MANUFACTURER: Recalling Firm: Medtronic Navigation, Inc., Louisville, CO, by site visits on November 27, 2007. Manufacturer: Medtronic Navigation, Inc., Littleton, MA. Firm initiated recall is complete.
REASON: Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker.

PRODUCT: Excelsior SL-10 Microcatheter, placed in sterile pouch. The ExcelsiorTM SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature; a) Model Number M0031681890, Catalog Number 168189, b) Model Number, M0031681810, Catalog Number 168181. Recall # Z-0627-2009
MANUFACTURER: Boston Scientific Corporation, Fremont, CA, by letter dated October 7, 2008. Firm initiated recall is ongoing.
REASON: Packaging issue may result in failure to maintain sterile barrier.

PRODUCT:
a) Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251. Recall # Z-0648-2009;
b) Stryker Medical Stair-PRO Stair-Chair with wheels and a track system, patient transport device, Model 6252. Recall # Z-0649-2009;
c) Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport device, Model 6253. Recall # Z-0650-2009
MANUFACTURER: Stryker Medical Division of Stryker Corp., Portage, MI, by letter dated November 18, 2008. Firm initiated recall is ongoing.
REASON: Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.

PRODUCT:
a) Terumo Advanced Perfusion System 1 Air Bubble Detection Module; Catalog number 802110. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. Recall # Z-0670-2009;
b) Terumo Advanced Perfusion System 1 Pressure Monitoring Unit; Catalog number 802112. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. Recall # Z-0671-2009;
c) Terumo Advanced Perfusion System 1 Temperature Monitoring Systems; Catalog number 802114. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. Recall # Z-0672-2009;
d) Terumo Advanced Perfusion System 1 Pressure Venous Occluder; Catalog number 803480. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. Recall # Z-0673-2009;
e) Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. Recall # Z-0674-2009
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter on November 16, 2007 and by e-mail on November 21, 2007. Firm initiated recall is ongoing.
REASON: The system may malfunction due to t-filter corrosion on an internal circuit board.

PRODUCT:
Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. Recall # Z-0837-2009
MANUFACTURER: Boston Scientific Corp., Fremont, CA, by letters on October 8, 2008. Firm initiated recall is ongoing.
REASON: Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.

PRODUCT:
a) REF: 915-1006 Lactosorb System, Lacto Endobrow Lift Complete, 10X13CM. (3.75X5.25") (WXL), Polypropylene, Radel. Non Sterile Product. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. Recall # Z-0864-2009;
b) REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriver, 1 Tap Handle, 1 Drill Bit, 1 Screw Extractor, 1 Self Drilling Tap, S/S. Aluminum , Teflon, Ra del. Non Sterile Product. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. Recall # Z-0865-2009;
c) REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypropylene, Radel, AL, SS, T.C. Non Sterile Product. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. Recall # Z-0866-2009;
d) REF 01-6851 Office System 1.5/IMF Small Office Set, 156MMX125MM, (6.4"X4.9") Polypropylene, Ultem, Radel, AL, SS. Non Sterile Product. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. Recall # Z-0867-2009
MANUFACTURER: Biomet Microfixation, Inc., Jacksonville, FL, by letters on August 26, 2008, August 27, 2008, September 26, 2008, October 28, 2008 and November 13, 2008. Firm initiated recall is ongoing.
REASON: The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.

PRODUCT: Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. Catalog No. 6276-7-017 (17mm), Catalog No. 6276-7-014, (14mm). Recall # Z-0884-2009
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on November 21, 2008. Manufacturer: Stryker Ireland, Ltd., Orthopedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON: Stryker became aware of a lot for lot mix up.

PRODUCT: Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Recall # Z-0887-2009
MANUFACTURER: Regenesis Biomedical Inc., Scottsdale, AZ, by letter dated September 29, 2008. Firm initiated recall is complete.
REASON: Under certain unusual clinical circumstance, the affected devices may be unable to generate a therapeutic dose of radio frequency energy. As such, for these few devices, the effectiveness of Provant therapy may be impaired.

PRODUCT:
a) Solar Shoulder Humeral Stem. These devices are modular components of a total shoulder system. These humeral stems are intended for use with humeral heads and glenoid components in primary or revision total shoulder arthroplasty. Catalog Numbers, Description 5351-4103 SHOULDER - HUMERAL STEM 7mm, 5351-4105 SHOULDER - HUMERAL STEM 9mm, 5351-4105 SHOULDER - HUMERAL STEM 9mm, 5351-4107 SHOULDER - HUMERAL STEM 11mm, 5351-4108 SHOULDER - HUMERAL STEM 12mm, 5351-4108 SHOULDER - HUMERAL STEM 12mm, 5351-4109 SHOULDER - HUMERAL STEM 13mm VWHMKE, 5351-4110 SHOULDER - HUMERAL STEM 14mm HTXMKE, 5351-4110 SHOULDER - HUMERAL STEM 14mm, 5351-4113 SHOULDER - HUMERAL STEM 17mm, and 5351-4205 SHOULDER - HUMERAL 200mmX9mm. Recall # Z-0888-2009;
b) Triathlon Cemented Stem - Knee These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty. Item Number, Product Name: 5560-S-209 TRI CEMENTED STEM 9MMX100MM and 5560-S-209 TRI CEMENTED STEM 9MMX100MM. Recall # Z-0889-2009;
c) Triathlon-Press-Fit Stem These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty. Catalog numbers, Description: 5565-S-015 TRI PRESS-FIT STEM 15MM X 100MM, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM, 5565-S-017 TRI PRESS-FIT STEM 17MM X 100MM, 5566-S-012 TRI PRESS-FIT STEM 12X150MM, 5566-S-013 TRI PRESS-FIT STEM 13X150MM, and 5566-S-018 TRI PRESS-FIT STEM 18X150MM. Recall # Z-0890-2009;
d) Omnifit HA Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6017-0525A OMNIFIT HA HIP STEM #5 and 6017-1035A OMNIFIT HA HIP STEM #10. Recall # Z-0891-2009;
e) Omnifit Normalized Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6034-0730 OMNIFIT NORMALIZED HIP STEM. Recall # Z-0892-2009;
f) Secur-Fit Max Hip Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: 6051-0625S SECUR-FIT MAX 132 HIP STEM #6, 6051-0730S SECUR-FIT MAX 132 HIP STEM #7, 6051-0730S SECUR-FIT MAX 132 HIP STEM #7, 6051-0830S SECUR-FIT MAX 132 HIP STEM #8, 6051-0830S SECUR-FIT MAX 132 HIP STEM #8, 6051-0935S SECUR-FIT MAX 132 HIP STEM #9, 6051-1035S SECUR-FIT MAX 132 HIP STEM #10, 6051-1140S SECUR-FIT MAX 132 HIP STEM #11, 6051-1140S SECUR-FIT MAX 132 HIP STEM #11, 6052-0830S SECUR-FIT MAX 127 HIP STEM #8, 6052-0935S SECUR-FIT MAX 127 HIP STEM #9, 6052-1035S SECUR-FIT MAX 127 HIP STEM #10, 6052-1035S SECUR-FIT MAX 127 HIP STEM #10 and 6052-1240S SECUR-FIT MAX 127 HIP STEM #12. Recall # Z-0893-2009;
g) Primary Secur-fit Plus Max Hip Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: 6054-0812S PRIMARY SECUR-FIT PLUS MAX #8/12, 6054-0812S PRIMARY SECUR-FIT PLUS MAX #8/12, 6054-0915S PRIMARY SECUR-FIT PLUS MAX #9/15, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14 and 6054-1218S PRIMARY SECUR-FIT PLUS MAX #12/18. Recall # Z-0894-2009;
h) Accolade C CS. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6057-0335D ACCOLADE C CS 127 NK, 6057-0537D ACCOLADE C CS 127 NK, 6057-0740D ACCOLADE C CS 127 NK and 6058-0335D ACCOLADE C CS 132 NK. Recall # Z-0895-2009;
i) Omnifit HFX Hip Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 and 6070-1140A OMNIFIT HFX HIP STEM SIZE #11 132. Recall # Z-0896-2009;
j) Accolade HFx. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog # Description: 6077-0230 Accolade HFx Size #2, 6077-0230 Accolade HFx Size #2, 6077-0335 Accolade HFx Size #3, 6077-0435 Accolade HFx Size #4, 6077-0435 Accolade HFx Size #4 and 6077-0435 Accolade HFx Size #4. Recall # Z-0897-2009;
k) Omnifit FC Cemented Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6093-1035 OMNIFIT-FC CEMENTED STEM and 6093-1035 ONMIFIT FC CEMENTED STEM. Recall # Z-0898-2009;
l) Omnifit Eon. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6098-0630 OMNIFIT EON 132, 6098-0630 OMNIFIT EON 132, 6098-0735 OMNIFIT EON 132, 6098-0940 OMNIFIT EON 132 and 6098-1140 OMNIFIT EON 132. Recall # Z-0899-2009;
m) Japanese Omnifit Eon 127 NK. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Item number: J6097-0425, Item number J6097-05390. Recall number: Z-0900-2009;
n) Reunion HA Fracture Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: R5351-4507 REUNION HA FRACTURE STEM 7MM, R5351-4508 ReUnion HA Fracture Stem 8MM, R5351-4508 ReUnion HA Fracture Stem 8MM and R5351-4509 REUNION HA FRACTURE STEM 9MM. Recall # Z-0901-2009;
o) Secur-Fit ARC/HA Collar Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: S-2337-HF09 SECUR-FIT ARC/HA COLLAR STEM #9, S-2337-HF09 SECUR-FIT ARC/HA COLLAR STEM#9 and S-2337-HF10 SECURFIT ARC/HA COLLAR STEM#10. Recall # Z-0902-2009
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on November 21, 2008. Firm initiated recall is ongoing.
REASON: Stryker Orthopedics became aware of a visual defect in certain blister packages of certain devices.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 4, 2009:
CLASS II
PRODUCT:
a) Medtronic SynchroMed EL Programmable Pump, Model 8626-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0583-2009;
b) Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0584-2009;
c) Medtronic SynchroMed EL Programmable Pump, Model 8626-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0585-2009;
d) Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0586-2009;
e) Medtronic SynchroMed EL Programmable Pump, Model 8627-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0587-2009;
f) Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0588-2009;
g) Medtronic SynchroMed EL Programmable Pump, Model 8627-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0589-2009;
h) Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. Recall # Z-0590-2009;
i) Medtronic SynchroMed II Programmable Pump, Model 8637-20. 20 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed II programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follosing drugs or fluids: -chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free morphine sulfate sterile solution. - chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of serve chronic pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. -chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen Injection). -Chronic intravascular infusion of floxuridine, (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency. Recall # Z-0591-2009;
j) Medtronic SynchroMed II Programmable Pump, Model 8637-40. 40 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed II programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follosing drugs or fluids: -chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free morphine sulfate sterile solution. - Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of serve chronic pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. – Chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen Injection). - Chronic intravascular infusion of floxuridine, (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency. Recall # Z-0592-2009
MANUFACTURER: Medtronic Neuromodulation, Minneapolis, MN, by letter beginning August 25, 2008. Firm initiated recall is ongoing.
REASON: Medtronic issued a letter to healthcare professionals providing important safety information regarding MRI (magnetic resonance imaging) effects on SynchroMed EL and SynchroMed II implantable infusion pumps. As stated in product labeling, the magnetic field of an MRI will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of MRI exposure for all SynchroMed pumps. The pump should resume normal operation when removed from the MRI magnetic field, however new information has been identified related to the following MRI effects: 1) There is the potential for a delay in the return of proper drug infusion after an MRI (this affects all SynchroMed pumps) and 2) There is the potential for a delay in the logging of motor stall events after an MRI (this only affects SynchroMed II pumps).

PRODUCT: Liko AB Uno Lifts, Powered (non-AC) Patient Lift: a) Uno 100 EM/EE; b) Uno 101. Uno 100 and 102 are battery powered mobile lifts, designed to be used in most of the common lifting situations, for example transfers between bed and wheelchair, to and from the toilet and bathtub or for lifting to and from the floor. Recall # Z-0605-2009
MANUFACTURER: Recalling Firm: Liko North America Inc., Franklin, MA, by letter dated December 5, 2008. Manufacturer: Liko AB, Lulea, Sweden. Firm initiated the recall is ongoing.
REASON: Actuator of the lift has potential to separate when the upper arm is fully extended.

PRODUCT: DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers. Recall # Z-0609-2009
MANUFACTURER: Recalling Firm: Medtronic Cardiovascular Revascularization & Surgical Therap, Brooklyn Park, MN, by letter dated October 1, 2008. Manufacturer: Atek Medical Manufacturing, Grand Rapids, MI. Firm initiated recall is ongoing.
REASON: Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no adverse events affecting these patients.
PRODUCT: a) CAD SCIENCES LLC 3 TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response. Recall # Z-0653-2009;
b) CAD SCIENCES LLC 3 TP PrecisionPointTM Software, for biopsy guidance. Recall # Z-0654-2009;
MANUFACTURER: iCAD, Inc., Nashua, NH, by telephone and letter on December 5, 2008. Firm initiated recall is ongoing.
REASON: Software modules not approved for this indication.

PRODUCT:
a) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe. Product Code EPS01. Recall # Z-0655-2009;
b) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe. Product Code EPS02. Recall # Z-0656-2009;
c) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Right Angle Probe. Product Code EPS03. Recall # Z-0657-2009;
d) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe. Product Code EPS04. Recall # Z-0658-2009;
e) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe. Product Code EPS05. Recall # Z-0659-2009;
f) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe. Product Code EPS06. Recall # Z-0660-2009;
g) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe. Product Code EPS07. Recall # Z-0661-2009;
h) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe. Product Code EPS08. Recall # Z-0662-2009;
i) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe. Product Code EPS09. Recall # Z-0663-2009;
MANUFACTURER: Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letters on December 9, 2008. Manufacturer: Ethicon Endo-Surgery, Inc. S.A. de C.V. Planta II, Ciudad Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON: Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sensitivity or could sensitize certain patients to nickel exposure in the future.

PRODUCT: Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number: SC1439-1000. Recall # Z-0664-2009
MANUFACTURER: Stelkast Co., McMurray, PA, by telephone on October 7, 2008. Firm initiated recall is complete.
REASON: Sterility may be compromised due to breach in packaging.

PRODUCT:
a) Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation. Recall # Z-0665-2009;
b) Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation. Recall # Z-0666-2009;
c) Maximo II CRT D284TRK, for ventricular pacing and defibrillation. Recall # Z-0667-2009;
MANUFACTURER: Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Mounds View, MN, by letter dated July 30, 2008. Manufacturer: Medtronic Puerto Rico Operations Company, Juncos, PR. Firm initiated recall is ongoing.
REASON: Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. Although the algorithm is operating correctly, it is not accessible to the clinician for reprogramming.

PRODUCT: Stratus CS Acute Care Troponin I TestPak, Catalog number: CCTNI, in vitro diagnostic, Recall # Z-0668-2009
MANUFACTURER: Dade Behring, Inc., Newark, DE, by letter dated June 23, 2008. Firm initiated recall is complete.
REASON: Incorrect result: Potential for false elevation of CTnl results.

PRODUCT: Hardy Diagnostic McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box. Model number: Hardy = MS05. Recall # Z-0669-2009
MANUFACTURER: Recalling Firm: Trek Diagnostic Systems, Cleveland, OH, by letter on September 22, 2008. Manufacturer: Hardy Diagnostics, Santa Maria, CA. Firm initiated recall is ongoing.
REASON: Incorrect result: The absorbance has changed as the standards have aged; the standards’ turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK’S internal specification and the manufacturer’s (Hardy Diagnostics) specification is 0.08 – 0.10 ABS @ 625 nm. CLSI specifies 0.08 – 0.13 ABS @ 625 nm.

PRODUCT: GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. Recall # Z-0836-2009
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated December 12, 2008. Firm initiated recall is ongoing.
REASON: There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it.

PRODUCT:
a) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/18 cm, sterile; Ref EUSCFS-060018-10-13; GPN REF G18116. Ureteral stent. Recall # Z-0839-2009;
b) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile; Ref EUSCFS-060020-10-13; GPN REF G18117. Ureteral stent. Recall # Z-0840-2009;
c) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/22 cm, sterile; Ref EUSCFS-060022-10-13; GPN REF G18118. Ureteral stent. Recall # Z-0841-2009;
d) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile; Ref EUSCFS-060024-10-13; GPN REF G18132. Ureteral stent. Recall # Z-0842-2009;
e) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile; Ref EUSCFS-060026-10-13; GPN REF G18119. Ureteral stent. Recall # Z-0843-2009;
f) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/28 cm, sterile; Ref EUSCFS-060028-10-13; GPN REF G18120. Ureteral stent. Recall # Z-0844-2009;
g) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/30 cm, sterile; Ref EUSCFS-060030-10-13; GPN REF G18121. Ureteral stent. Recall # Z-0845-2009;
h) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/18 cm, sterile; Ref EUSCFS-070018-14-13; GPN REF G18641. Ureteral stent. Recall # Z-0846-2009;
i) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/20 cm, sterile; Ref EUSCFS-070020-14-13; GPN REF G18123. Ureteral stent. Recall # Z-0847-2009;
j) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/22 cm, sterile; Ref EUSCFS-070022-14-13; GPN REF G18133. Ureteral stent. Recall # Z-0848-2009;
k) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/24 cm, sterile; Ref EUSCFS-070024-14-13; GPN REF G18125. Ureteral stent. Recall # Z-0849-2009;
l) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile; Ref EUSCFS-070026-14-13; GPN REF G18127. Ureteral stent. Recall # Z-0850-2009;
m) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/28 cm, sterile; Ref EUSCFS-070028-14-13; GPN REF G18134. Ureteral stent. Recall # Z-0851-2009;
n) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/30 cm, sterile; Ref EUSCFS-070030-14-13; GPN REF G18130. Ureteral stent. Recall # Z-0852-2009;
o) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile; Ref EUSCFS-060026-10-13; GPN REF G18131. Ureteral stent. Recall # Z-0853-2009
MANUFACTURER: Vance Products, Inc., Spencer, IN, by letter dated July 31, 2008. Firm initiated recall is ongoing.
REASON: The bond may break where the two materials meet, resulting in separation of the stent.

PRODUCT: Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only; Catalog number: R6357A (12 mm), Catalog number: R6397A (16 mm). Recall # Z-0854-2009
MANUFACTURER: Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letters on October 22, 2008 and January 5, 2009. Manufacturer: Instrumed International, Inc., Schaumburg, IL. Firm initiated recall is ongoing.
REASON: A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa.

PRODUCT: a) CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device. Recall # Z-859-2009;
b) CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2794-0 Bonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device, Recall # Z-860-2009
MANUFACTURER: Fresenius Medical Care North America, Waltham, MA, by e-mail and telephone on November 25, 3008, and by letters on November 26, 2008, December 2, 2008 and December 3, 2008. Firm initiated recall is ongoing.
REASON: Port may crack and separate resulting in potential blood exposure/blood loss for the patient.

PRODUCT: a) Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14 MM Height, nonsterile; REF 5971-50-14. Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable. Recall # Z-0885-2009;
b) Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 12 MM Height, nonsterile; REF 5971-50-12. Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable. Recall # Z-0886-2009
MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter dated December 12, 2008 and by e-mail on December 15, 2008. Firm initiated recall is ongoing.
REASON: Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa.

PRODUCT: a) Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile; Cuff type A70107010. Each cuff is marked ExpressAire by Sammons Preston and A70107010. The tourniquet cuff is placed on a patient's thigh during an operation procedure of the lower leg. The cuff is not operational until it is attached to an air pump supply that is owned by the care giving facility (hospital). Recall # Z-0907-2009;
b) Expressaire, Disposable Tourniquet Cuff 34", 2 line (18), sterile; Cuff type A70107011. Each cuff is marked ExpressAire by Sammons Preston and A70107011. The tourniquet cuff is placed on a patient's thigh during an operation procedure of the lower leg. The cuff is not operational until it is attached to an air pump supply that is owned by the care giving facility (hospital). Recall # Z-0908-2009
MANUFACTURER: Virtus, Inc., Batesville, IN, by letter dated November 24, 2008. Firm initiated recall is ongoing.
REASON: The inflation tube may come loose at the connection to the cuff during use.

PRODUCT: Somatom Definition AS, Model number: 8098027. Computed tomography x-ray system. Recall 3 Z-0929-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated November 25, 2008. Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON: Possible improper installation of tilt transport lock/tilt limiter.
CLASS III
PRODUCT: Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. NOTE: None distributed domestically. Cranio-maxillofacial manual instrumentation to be used to aid in the treatment and care of patients, as determined appropriate, by a trained medical professional. The Obwegeser Ramus Clamps are self-retaining clamps, used on the ascending ramus of the mandible with an extension on one of the blades (shields) to aid in retracting the soft tissue of the cheek. Recall # Z-0906-2009
MANUFACTURER: Biomet Microfixation, Inc., Jacksonville, FL, by e-mail on May 21, 2008. Firm initiated recall is complete.
REASON: The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997.P

RODUCT: AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. The AMS collagen dermal matric is intended for use in the treatment of hernias where connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, or gastroenterological anatomy. Recall # Z-0932-2009
MANUFACTURER: American Medical Systems, Inc., Minnetonka, MN, by telephone on December 5, 2008. Firm initiated recall is ongoing.
REASON: The product size shown on the carton labeling does not match the size on the product inside.

PRODUCT: Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene Product Code: 0151531. Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest wall defects. It is designated in two orientations - "Right" and "Left" for use to the right or left side of the human body. There is a blue monofilament Medial marker "M" and a small arrow stitched into each orientation to designate the right or left medial edge of the product. Recall # Z-0935-2009
MANUFACTURER: Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter dated December 25, 2008. Manufacturer: Bard Shannon Limited, Humacao, PR. Firm initiated recall is ongoing.
REASON: Mislabeled; Product labeled as left large, may contain a Right Large.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of January 28, 2009:

CLASS II
PRODUCT: NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis. Recall # Z-0001-2009
MANUFACTURER: Recalling Firm: Philips Medical Systems, North America Co. Phillips, Bothell, WA, by letter during June 2008. Manufacturer: Philips and Neusoft Medical Systems Co., Ltd, Shenyang, Liaoning, China. Firm initiated recall is ongoing.
REASON: An issue associated with the “Timed Scan” application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met.

PRODUCT:
a) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System. The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-0473-2009;
b) GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System. The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-0474-2009;
c) GE Innova 4100 /4100 IQ. , The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-0475-2009
MANUFACTURER: Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated February 28, 2008. Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON: Software error, computer: GE Healthcare has become aware of an issue with Error Management affecting the Innova 2100, 3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was pressed, the live monitor screen was blank and it looked like there were no X-rays being emitted. But the message "Acquisition in progress" was displayed on the DL monitor, even after the foot switch was released. The operator had to reset the system to clear the message. This issue raises potential safety concerns in particular in the X RAY and motion controls if the error management does not work properly. No injury was reported. However, the patient received a low, unnecessary x-ray dose.

PRODUCT: Hill-Rom 70 Semi-Electric Bed; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment. Recall # Z-0506-2009
MANUFACTURER: Recalling Firm: Hill-Rom, Inc., Batesville, IN, by letter dated November 11, 2008. Manufacturer: Power Metal Industry Kunshan Co., Lt, Kunshankunshan, China. Firm initiated recall is ongoing.
REASON: Failure, mechanical: If the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or when the patient exits the bed.

PRODUCT:
a) Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the processing and is centrifugation of urine prior to microscopic analysis in compliance with CLIA regulations. Recall # Z-0513-2009;
b) Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis reagent strips, and as a control for confirmatory tests such as Acetest, Clinitest, and Icotest reagent tablets, and as a control for hCG methods. In addition, the Dip and Spin Control is intended as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment. Recall # Z-0514-2009;
c) Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. Spinalscopics is a plastic bottle liquid spinal fluid cell count control. This product is intended for monitoring cell counts in patient cerebrospinal fluid samples performed manually using a hemocytometer. Recall # Z-0515-2009;
d) Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation. Recall # Z-0516-2009
MANUFACTURER: Quantimetrix Corp., Redondo Beach, CA, by letter dated June 8, 2008. Firm initiated recall is complete.
REASON: This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.

PRODUCT: Vertical drive brake on patient supports. Used on certain Philips Medical Systems MX series and Brilliance series CT scanners. The device is a vertical drive brake that controls the vertical position of a patient support system or couch. The patient support system is intended to be used to place the patient in the correct horizontal and vertical position in order to be scanned. The couch is an accessory product to a computed tomography scanner. Recall # Z-0597-2009
MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters on November 15, 2007 and June 6, 2008. Firm initiated recall is ongoing.
REASON: The patient support may travel downwards without being commanded to move.

PRODUCT:
a) Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 54" Model: 72108. Recall # Z-0598-2009;
b) Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 70" Model: 72109.
Recall # Z-0598-2009
MANUFACTURER: AliMed Corp., Dedham, MA, by letter dated October 30, 2008. Firm initiated recall is ongoing.
REASON: Misassembled gait (transfer aid) belt.

PRODUCT:
a) Esmark Elastic Bandage, 3” x 4” yards, sterile, for single use only, latex free. Catalog number: 23580-034. The device is used to promote blood flow from the extremities by compressing the superficial vessels. Recall # Z-0615-2009;
b) Esmark Elastic Bandage, 4” x 3” yards, sterile, for single use only, latex free. Catalog number: 23580-043. The device is used to promote blood flow from the extremities by compressing the superficial vessels, Recall # Z-0616-2009
MANUFACTURER: Recalling Firm: Cardinal Health, McGaw Park, IL, by letter dated November 17, 2008. Manufacturer: Convertors De Mexico, S.A. De C.V., Ciudad, Juarez, Mexico. Firm initiated recall is ongoing.
REASON: The natural rubber latex bandages were mislabeled as latex free.

PRODUCT: Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and 0682-000-416 (Flat Panel Retro Fit Kit); The 0682-000-414 (FP Shroud version 2 reworked) is a shroud designed to cover the cabling necessary on a Stryker Version 3 Monitor when mounted on the Flat Panel Arm.  Recall # Z-0625-2009
MANUFACTURER: Recalling Firm: Stryker Communications Corp., Flower Mound, TX, by letter on September 2, 2008 Manufacturer: Ondal Indust Gmbh, Hunfeld, Germany. Firm initiated recall is ongoing.
REASON: Paint chips: Shroud used to cover cables on the Stryker Vision 3 flat panel monitor (monitor used in surgery rooms during procedures) was not manufactured/painted to specification, resulting in the possibility that paint chips could fall off and fall into non-sterile and/or sterile fields during surgery.

PRODUCT: Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or therapeutic devices. Pre' Lubricant is acceptable for use to facilitate insertion of diagnostic or therapeutic devices during fertility interventions such as: embryo transfer, transvaginal collection of oocytes, intrauterine insemination and post coital testing. In addition, product may be used as a personal lubricant to supplement the body's own natural lubricating fluids. Recall # Z-0626-2009
MANUFACTURER: Recalling Firm: INGfertility, LLC, Valleyford, WA, by telephone on September 22, 2008. Manufacturer: Unicep Packaging, Inc., Sandpoint, ID. Firm initiated recall is ongoing.
REASON: Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).

PRODUCT: TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. TomoTherapy HI-ART Systems is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital health tissue. The HI-Art system's planning station or operator station is intended to be used by the physician/oncologists to prescribe a radiation therapy plan for a particular patient,. The HI-ART System then calculates the treatment plan which the physician reviews and approves. The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage (MVCT) scan (a CT using the on board linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The TomoImage (MVCT) image is not for diagnostic use. When patient positioning is complete, the HI-ART System i sthen intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern. Recall # Z-0628-2009
MANUFACTURER: TomoTherapy, Inc., Madison, WI, by letter dated October 17, 2008. Firm initiated recall is ongoing.
REASON: A potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access to these settings has always been restricted to individuals with appropriate security rights, being limited to only the "Superuser" and "Field Service engineer" categories. Other security level users, including "Therapist", cannot modify these settings. In the calibration panel, it is possible for "Superuser" and "Field Service Engineer" user types to manually disable the front and back jaw potentiometer interlock. This interlock is always correctly enabled prior to factory shipment of systems from TomoTherapy, and there are no service procedure that requires the interlock to be disabled. If this setting were to be manually disabled, the jaw would not perform a verification of the pre-procedure homing routine. In the unlikely event that this verification routine failed in a rare and very specific manner, the jaws could position incorrectly for that procedure without a system interlock occurring. This positioning error could only result in a field width that is smaller than planned. Fractions that would be affected would only be those incurring the unusual chain of events outlined above. Regardless, overdose in not a possible outcome.

PRODUCT: Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0. Product is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-0629-2009
MANUFACTURER: Accuray, Inc., Sunnyvale, CA, by letter dated November 14, 2008. Firm initiated recall is ongoing.
REASON: System may use random incorrect data to calculate dose. Resulting dose calculation can exceed 100% of correct dose.

PRODUCT: Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump. Recall # Z-0652-2009
MANUFACTURER: Stryker Endoscopy, San Jose, CA, by letter on October 1, 2008. Firm initiated recall is ongoing.
REASON: Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery.

PRODUCT:
a) Tornier AFFINITI Humeral Stem Standard 10mm, Catalog No. 0020010. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0818-2009;
b) Tornier AFFINITI Humeral Stem Standard 14mm, Catalog No. 0020014. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0819-2009;
c) Tornier AFFINITI Humeral Head Eccentric 44mm x 18mm, Catalog No. 0020025. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0820-2009;
d) Tornier AFFINITI Humeral Head Eccentric 44mm x 21mm, Catalog No. 0020026. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0821-2009;
e) Tornier AFFINITI Humeral Head Eccentric 48mm x 21mm, Catalog No. 0020030. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0822-2009;
f) Tornier AFFINITI Humeral Head Eccentric 52mm x 21mm, Catalog No. 0020034. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0823-2009;
g) Tornier AFFINITI Humeral Head Eccentric 56mm x 21mm, Catalog No. 0020038. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0824-2009;
h) Tornier AFFINITI Humeral Head Standard 44mm x 15mm, Catalog No. 0020044. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0825-2009;
i) Tornier AFFINITI Humeral Head Standard 44mm x 18mm, Catalog No. 0020045. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0826-2009;
j) Tornier AFFINITI Humeral Head Standard 44mm x 21mm, Catalog No. 0020046. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0827-2009;
k) Tornier AFFINITI Humeral Head Standard 48mm x 15mm, Catalog No. 0020048. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0828-2009;
l) Tornier AFFINITI Humeral Head Standard 48mm x 18mm, Catalog No. 0020049. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0829-2009;
m) Tornier AFFINITI Humeral Head Standard 48mm x 21mm, Catalog No. 0020050. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0830-2009;
n) Tornier AFFINITI Humeral Head Standard 52mm x 15mm, Catalog No. 0020052. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0831-2009;
o) Tornier AFFINITI Humeral Head Standard 52mm x 18mm, Catalog No. 0020053. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0832-2009;
p) Tornier AFFINITI Humeral Head Standard 52mm x 21mm, Catalog No. 0020054. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0833-2009; 
q) Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020057. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0834-2009;
r) Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020058. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0835-2009
MANUFACTURER: Recalling Firm: Tornier, Stafford, TX, by letter dated October 17, 2008. Manufacturer: Micropulse, Inc., Columbia City, IN. Firm initiated recall is ongoing.
REASON: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AFFINITI Stems.

PRODUCT:
Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-090-650, 3910-090-652, 3910-090-800, and 3910-090-802. The obturator is used to create an opening into the patient's joint and is removed after the cannula is inserted. The cannula then allows instruments and scopes access to the joint while maintaining a seal against the loss of saline fluid used to keep the joint clean. The seal is formed by two elastomeric valves. The first controls loss of water when there is no instrument or scope therein, while the second provides a seal when the cannula is in use. The valves operate automatically. Recall # Z-0868-2009
MANUFACTURER: Recalling Firm: Stryker Endoscopy, San Jose, CA, by telephone, e-mail and letter dated December 1, 2008. Manufacturer: Stryker, Arroyo, PR. Firm initiated recall is ongoing.
REASON: Leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of January 21, 2009:

CLASS II
PRODUCT: Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file, Recall # Z-0129-2009
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated October 17, 2007. Manufacturer: Beckman Coulter, Inc., Fullerton, CA. Firm initiated recall is complete.
REASON: Software error: The CXP software does not refresh the dataset automatically under certain circumstances. The User documentation does not clearly state that the user should refresh the dataset after changes is made.

PRODUCT:
a) Mainline Confirms Strep A, 1) Catalog # 3030-20 and 2) Catalog # 3030-40, Recall # Z-0525-2009;
b) Mainline Confirms Strep A DOTS, Catalog # 4040, Recall # Z-0526-2009;
c) Mainline Confirms III Serum/Urine control set, Catalog # 3029-CTR, Recall # Z-0527-2009;
d) Mainline hCG Accuracy Check, Catalog # 3c1001, Recall # Z-0528-2009;
e) Mainline Confirms hCG Serum/Urine III, Catalog # 3029-25, Recall # Z-0529-2009;
f) f.y.i. hCG Urine one-step pregnancy test, Catalog # 43065, Recall # Z-0530-2009
g) Mainline Confirms hCG urine pregnancy test, Catalog # 6008C, Recall # Z-0531-2009
MANUFACTURER: Mainline Technology, Inc., Ann Arbor, MI, by letter dated August 18, 2008. Firm initiated recall is ongoing.
REASON: Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.

PRODUCT:
a) Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD, sterile, Depuy France; REF 130738203. The device is used as a shoulder implant. Recall # Z-0532-2009;
b) Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device is used as a shoulder implant, Recall # Z-0533-2009;
c) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF 130738209. The device is used as a shoulder implant, Recall # Z-0534-2009;
d) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130738106. The device is used as a shoulder implant, Recall # Z-0535-2009; 
e) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF 130742203. The device is used as a shoulder implant, Recall # Z-0536-2009; 
f) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 130742206. The device is used as a shoulder implant, Recall # Z-0537-2009;
g) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 130742209. The device is used as a shoulder implant, Recall # Z-0538-2009;
h) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy France; REF 130742106. The device is used as a shoulder implant, Recall # Z-0539-2009
MANUFACTURER: Depuy Orthopaedics, Inc., Warsaw, IN, by letter dated July 8, 2008 and July 15, 2008. Firm initiated recall is complete.
REASON: Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable.

PRODUCT:
1) Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01. The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon. Recall # Z-0546-2009;
2) Bed Check Model #'s: BED65815-021 BED65815-025 BED65815-025IT BED65815-030 BED65815-031 BED73000 BED73010 BED74000 BED74010 NURBPP-30A NURBPP-30WC POS8283 RFT1000-1210 RFT1000-1250 RFT1000-1810 and RFT1000-1820. A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed. Recall # Z-0547-2009;
3) Drill Bits Model #'s: DEP14043 MIC8053-019 RIC21-0438 RIC21-0439 RIC21-0441 RIC21-0442 RIC71173504 RIC71173505 RIC71631117 SMI21-0445 STR5800-4-125 STR60-13570 SYN03.010.060 SYN03.010.061 SYN03.010.101 SYN310.19 SYN310.24 SYN310.25 SYN310.288 SYN310.31 SYN310.35 SYN310.431 SYN310.44 SYN310.63 SYN310.65 SYN310.66 SYN310.67 SYN315.28 SYN315.40 SYN315.92 SYN317.861 SYN317.871 SYN356.982 SYN357.407 ZIM00-2318-020-00 and ZIM5056-146. An orthopedic manual surgical instrument is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. Recall # Z-0548-2009;
4) Biopsy Forceps, Hot Model #'s: BAL60110 BAR000852 BAR000854 and MIC1550. Laparoscopic electric instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, resection, mobilization, and dissection of tissue. Recall # Z-0549-2009;
5) Burrs Model #'s: ANSL-3SB ANSL-5D ANSQD11-4OVDC HAL5056-118 HAL5056-166 HAL5091-106 HAL5091-112 HAL5091-122 HAL5091-125 HAL5091-136 HAL5091-144 HAL5091-164 HAL5092-120 HAL5092-168 HAL5092-170 KOM04-D0139 LIN5091-101 LIN5091-102 LIN5091-142 LIN5092-132 LIN5092-160 MED874-447 MICZB-228 MICZB-232 MID14CY50 MID14MH30D MIDG6-450 MIDG8-130 MIDMC254 STR1607-2-35 STR1608-6-137 STR1608-6-141 STR1608-6-149 STR277-10-62 STR5120-10-40 STR5120-10-50 STR5120-71-48 STR5300-10-511 STR5300-10-513 STR5300-10-903 STR5300-20-513 STR5300-30-903 XOM31-55641 ZIM5056-116 ZIM5056-117 ZIM5056-118 ZIM5056-125 ZIM5056-140 ZIM5056-150 ZIM5056-159 ZIM5056-161 ZIM5056-162 ZIM5056-164 and ZIM5056-167. Surgical instruments motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Recall # Z-0550-2009;
6) Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790. Intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. Recall # Z-0551-2009;
7) Colorado Electrodes Model #'s: COLN104A COLN112A and STRN103A. Intended for precision cutting or dissecting and cauterizing soft tissue. Recall # Z-0552-2009;
8) Compression Sleeves Model #'s: HUNDVT10-1 and KEN5329. The SterilMed Intermittent Compression Sleeve, 400 series used in conjunction with the Talley DVT-275 pump is indicated for any person that is at risk for deep vein thrombosis or could otherwise benefit from enhanced blood flow and circulation and/or a reduction in post operative pain and swelling. Recall # Z-0553-2009;
9) EP Cables Model #'s: BAR560004P BIOC10MR10MSTKS BIOC5-MH/NAVMH-S CORC6-MR10/EPTR-S DAI401972 DAI401976 DAI401977 DAI401981 DAI401983 EPT5454S EPT613 and EPT651. An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine. Recall # Z-0554-2009;
10) EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904 DAI401915 and EPT7003D. Intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation. Recall # Z-0555-2009;
11) External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86. Intended for use in the construction of an external fixation frame for treatment of a various fracture types that require external fixation. Recall # Z-0556-2009;
12) Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of the femoral artery or vein after cauterization. Recall # Z-0557-2009;
13) Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100. Intended to be used for selective cannulization of the billary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic billary procedures for catheter introduction and exchanges. Recall # Z-0558-2009;
14) Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and ETHLCSC5HA. Intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. Recall # Z-0559-2009;
15) Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643 ETH5DCD ETH5DCS ETHEBF01 ETHPOUCH GYR3000PK GYR3005PK GYR3640 and GYR920005PK. Laparoscopic electric instruments are designed for use in minimally invasive procedures and/or open surgical procedures to facilitate coagulation, transaction, resection, mobilization and dissection of tissue. Recall # Z-0560-2009;
16) Lap Instruments/Graspers/Forceps - COLD Model #'s: AUT173030 AUT174233 AUT174317 AUT176613 AUT176647 AUTECATCH10G and ETH5DSG. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. Recall # Z-0561-2009;
17) Laser Probe Model #': SYN55.26.25. Reprocessed laser probes are part of a laser delivery system and are used in ophthalmic procedures where laser energy is the mode of treatment. Recall # Z-0562-2009;
18) Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015 LMA12020 LMA12030 LMA12040 LMA12050 LMA12120 LMA12125 LMA12130 LMA12140 and LMA21140. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway. Recall # Z-0563-2009;
19) Multi-Clip Applier Model #'s: APPCA080 AUT134031 AUT134046 AUT134051 AUT134053 AUT176625 AUT176657 AUTPTACK30 ETHEL5ML ETHER320 ETHMCL20 ETHMCM20 ETHMCM30 ETHMCS20 ETHMSM20 and WEC543965. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. Recall # Z-0564-2009;
20) Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839 ALC8065750852 ALC8065790020 ALC8065790022 and ALLOPOR3020L. Intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens. Recall # Z-0565-2009;
21) Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. Recall # Z-0566-2009;
22) Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. Recall # Z-0567-2009;
23) RF Arthroscopy Probe Model #'s: ARTA1325-01 ARTA1335-01 ARTA1345-01 ARTA1730-01 ARTA2630-01 ARTA3625-01 ARTA4330-01 ARTAS1335-01 ARTAS4630-01 ARTASC1335-01 ARTASC2530-01 ARTASC4250-01 ARTASC4830-01 ARTASC5000-01 ARTASC5500-01 ARTEIC4845-01 MIT225203 MIT225301 MIT225302 MIT225305 MIT225350 MIT225360 SMI7209681 SMI7209682 SMI7209683 and STR278-510-500. These devices are designed for general surgical use, including orthopedic and arthroscopic applications or resection, ablation, excision of soft tissue, hemostatis of blood vessels, and coagulation of soft tissue. Recall # Z-0568-2009;
24) Saw Blade Model #'s: BIO506112 BIO506113 DEP2555-91-000 DEP5627-11-500 HAL5023-118 HAL5059-32 HAL5071-133 HAL5071-145 HAL5071-163 HAL5071-181 HAL5071-572 HOWHB-NST-6828-7-791 HOWHB-NST-6828-7-792 KOMK-2000-65 KOMKM-004 KOMKM-005 KOMKM-101 KOMKM-101C KOMKM-102 KOMKM-234 KOMKM-275R KOMKM-3101 KOMKM-3107 KOMKM3-225 KOMKM-325R KOMKM-619 KOMKM-660 KOMKM-693 LIN5023-170 MICSO-601 MICSO-610 MICSP-414A MICZO-062 MICZO-7052 MMM5756 STR2108-100 STR2108-102 STR2108-105 STR2108-107-4 STR2108-109 STR2108-110 STR2108-113 STR2108-115 STR2108-118 STR2108-120 STR2108-125 STR2108-140 STR2108-140-6 STR2108-148 STR2108-150 STR2108-150S2 STR2108-151 STR2108-152 STR2108-152-6 STR2108-158 STR2108-160 STR2108-161-2 STR2108-183 STR2108-185 STR2108-189 STR2108-192 STR2108-218 STR2108-302 STR2108-309 STR2108-351 STR2108-356 STR2296-3-103 STR2296-3-105 STR2296-3-111 STR2296-3-115 STR2296-3-125 STR2296-3-212 STR2296-3-225 STR2296-33-105 STR2296-33-111 STR2296-33-125 STR2296-3-412 STR2296-3-414 STR2296-3-511 STR277-88-100 STR277-88-125 STR277-96-250 STR277-96-275 STR277-96-277 STR277-96-325 STR277-96-326 STR298-97-100 STR4111-107-090 STR4125-089-075 STR4125-097-090 STR5100-137-233 STR5301-30-172 STR5301-40-33 STR6113-127-90 STR6125-89-75 SYN11-2217 SYN11-3500 SYN11-3534 TER98-0702-1234-9 ZIM5979-95-35 and ZIM5979-95-41 Surgical instruments motors and accessories are AC-powered, battery-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Recall # Z-0569-2009
25) Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152 SNO89-5100 and SNO89-5300. Intended to be used with a reusable hand piece and are designed to use in minimally invasive and open surgical procedures to facilitate coagulation, preparation, mobilization, and cutting tissue. Recall # Z-0570-2009;
26) Stone Retrieval Basket Model #': BOS390-10. Used to entrap and remove renal stones and calculi via a rig id or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures. Recall # Z-0571-2009;
27) Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002 SMI7010-7006 SMI7010-7007 SMI7010-7008 SMI7010-7010 SMI7010-7011 SMI7010-7012 SMI7010-7015 STR5921-018-136 STR5921-018-235 STR5921-024-135 STR5921-024-136 STR5921-024-146 STR5921-024-235 STR5921-030-135 STR5921-030-235 STR5921-034-135 STR5921-034-136 STR5921-034-235 STR5921-044-135 STR5921-044-136 STR5921-044-235 STR5921-212-135 ZIM60-7070-02 ZIM60-7070-03 ZIM60-7070-04 ZIM60-7070-05 ZIM60-7070-06 ZIM60-7070-07 ZIM60-7070-101 ZIM60-7070-102 ZIM60-7070-103 ZIM60-7070-104 ZIM60-7070-105 ZIM60-7070-106 ZIM60-7070-107 ZIM60-7075-006 ZIM60-7075-03 ZIM60-7075-04 ZIM60-7075-05 ZIM60-7075-06 ZIM60-7075-07 ZIM60-7075-101 ZIM60-7075-102 ZIM60-7075-103 ZIM60-7075-104 ZIM60-7075-106 ZIM60-7075-107 ZIM60-7080-102 and ZIM60-7080-103. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff, Recall Z-0572-2009;
28) TURP Electrodes Model #'s: CIRMLE-24-012 CIRMLE-24-015 OLYA22205C STO27050F STO27050G and STO27050NK. Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection for soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures. Recall # Z-0573-2009;
29) Open & Unused Items - This refers to a sterilization service provided by SterilMed, Inc. (devices were not reprocessed) for Class 1 and Class 2 devices that were opened, most likely in O. R. suites, in which for whatever reason the physician elected to select a different type of device, different size of device, or maybe elected to not use the device at all in a procedure. This is not a process regulated by FDA, but is included in the recall process as product would still be considered misbranded and or represent a potential risk to patients. Model #'s: ABB6543-01 ABB6544-01 ACM23116 ACR800-499 ACU014719 ALL2N2704X ALLASC1201 ALLF-5501 ALLSU130-404E ARTAR-6530 ARTAR-6540 ARTAR-6560 ARTAR-6562 ARTAR-6564 ARTAR-6570 AUT054887 AUT059035 AUT059037 AUT174001 AUT8886803712 AUTGIA6025S BAL60417 BAR0043620 BAR0070740 BAR0601110 BAR072231 BARBRD100R BAX2C4005 BER610 BIO418200 BIO631031 BOUTC001NSKA CARASU1510 COD26-1221 CON130309 CON130321 CON134006 CON1412 CON29410 CON29415H CON29496 CON60-6085-100 CON8535 CON9413 CON9448 COO081012 COO081014 COOCTI-512N COOTD-1 COOZSI1151 DAV0035280 DAV0043650 DEN50-7000 DEN50-7500 DER28-0211 DLP10012 EDWDSAFE61 EDWFEMII016A ETH10BB ETH2189 ETH2211 ETH5BB ETH6TB45 ETHBTD05 ETHPMW35 ETHPRW35 ETHPXW35 ETHUV120 FUT4549 GUIOM-9000S GUIXP-4000 GYR240060 GYR240072 GYR70138000 GYR7013-8100 GYR70140257 JOH2214 KEN31140240 KEN31140562 KEN8884720221 KEN8888505172 KIM111 KIM228 kim279 KIM311 KIM330 KIM345 KIM70321 KIM79043 KIM79870 KIM79878 KIM888 KIM89601 KIM95111 KIM95521 KIR10-4000 KIR10-4001 KIR14-3000 KRO6003 LIN9718 LINESA-5333 LINESA-5339 MECEPT03 MED05897/JP2311 MED10001S/JP10001 MED11348/DYNJP2500 MED14184/JP2414 MED14184A/JP2414A MED21394P/JP2302P MED2457S/JP8303 MED2505/JP2510 MED3110A/JP3003A MED3110S/JP3003 MED3130S/JP3008 MED3140S/JP3005 MED3820A/JP3102A MED3820S/JP3102 MED4202S/JP4003 MED6052-53 MED8610S/JP8005 MED91263 MED96570-021 MEDDYNJ01201H MEDDYNJ05933 MEDDYNJO5933 MEDDYNJP8201 MEDSPT-2314/JP2314HD MEG0012 MEG0020 MEG0035H MEG0039H MIC390-310 MIC6131 MIC6237 MIC670-308 MIC710-111 MIC81010 MPS5001689 OLS20-1410KI ORSORS-300 Q2M20-1370 RMITF-3646-0 SMI4116 SMI4615 SMI4616 SMI71111579 SMI7204727 SMI72200195 SPIXDWIK28 STR1608-2-59 STR1608-2-63 STR206-16 STR206-546 STR250-070-530 STR250-070-540 STR275-802-000 STR306-553 STR350-202-000 STR3910-075-500 STR3910-075-501 STR3910-075-650 STR3910-075-651 STR3910-075-800 STR400-800 STR501-140-50 STR5120-103-15 STR606-563 STR620-030-301 STR620-030-407 STR620-30-301 SYN55.36E SYNSDLB TELDP-40K TELMDP-40K TER5842 TERL7328 TEX311033-000 USE00712031 VALE1450-6 VALE1510 VALE2350H VALE2450H VALE2505-10FR VALE2515H VALE2516H WAL909009 WEC528235 WEL24-6001 XOM1014242 XOM10-46001 XOM1850200 XOM31-55631 XOM31-55632 XOM31-55636 XOM31-55637 XOM31-55638 and XOM8225825, Recall # Z-0574-2009;
30) Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337 MIC1536 MIC1589 MIC1597 MIC1598 and MIC1599. The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination. Recall # Z-0575-2009;
31) Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32. An orthopedic manual surgical instrument is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Recall # Z-0576-2009;
32) Reamers Model #'s: HAL5091-144 and ZIMS5979-95-41. An orthopedic manual surgical instrument is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery, devices individually packaged and sealed within a pouch. Recall # Z-0577-2009.
MANUFACTURER: Sterilmed, Inc., Osseo, MN, by visit on August 8, 2008, by fax or email, on site visits on August 11, 2008 and by letter on August 14, 2008. Firm initiated recall is complete.
REASON: The possibility exists that some of the pouches were not properly sealed on one end.

PRODUCT: ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. The device is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The product is used to calibrate assays used to determine bilirubin concentrations in neonate and adult patient samples, Recall # Z-0580-2009.
MANUFACTURER: Abbott Laboratories, Inc., South Pasadena, CA, by letter on September 12, 2008. Firm initiated recall is ongoing.
REASON: The matrix of the secondary standard used in the value assignment of the calibrator is sensitive to the Diazo method. The matrix of this secondary standard caused a positive bias.

PRODUCT: Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3. The system is a discrete, random-access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids for in vitro diagnostic use. Recall # Z-0581-2009.
MANUFACTURER: Dade Behring, Inc., Newark, DE, by telephone and follow-up letter dated September 8, 2008. Firm Initiated recall is ongoing.
REASON: Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded.

PRODUCT: Quantum Pulse machine. The device is used to create light wave frequencies to effect cellular activity. Recall # Z-0582-2009
MANUFACTURER: VIBE Technologies, Greeley, CO, by letter on September 16, 2008. Firm initiated recall is ongoing.
REASON: Medical Device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.

PRODUCT: Foot switch, Part Numbers: 1009.81, 1009.81A0, 1009.81A1, 1009.81A2, 1009.81A3, 1009.81B0, 1009.81B1, 1009.81B2, 1009.81C0, 1009.81C1, 1009.81D0, 1009.81D1, 1009.81D2, 1009.81D3, 1009.81D4, 1009.81E0, 1009.81E1, 1009.81E2, 1009.81E3, 1009.81F0, 1009.81F1, 1009.81F2, 1009.81F3, 1009.81G0, 1009.81G1 and 1009.81G2.  The foot switches in the 1009.81 series are accessory components which can be connected to certain MAQUET operating tables. Several of the table top adjustment motions (depending on the table and foot switch versions in use) can then be executed by the foot. The foot switch is equipped with rocker switches. The switching elements are used to initiate the table top functions. Recall # Z-0620-2009.
MANUFACTURER: Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letter on December 8, 2008. Manufacturer: Maquet Aktiengesellschaft, Rastatt, Germany. Firm initiated recall is ongoing.
REASON: A bearing point of the pedal of the foot switch may come loose. With continued use of the foot switch, one or both springs beneath the pedal can fall out of their mounting, and it is possible the pedal comes to rest on the switch causing an unintended motion of the operating table during patient use.

PRODUCT: Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48. Indicated for planning proton treatment of neoplasms of the eye.
MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter October 2, 2008. Firm initiated recall is ongoing.
REASON: When using the multiple static segment option, the device may alter dose delivery.PRODUCT: RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007. The CyberKnife is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The RoboCouch Patient Support System is intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required. Recall # Z-0856-2009.
MANUFACTURER: Accuray, Inc., Sunnyvale, CA, by letter dated October 30, 2008. Firm initiated recall is ongoing.

REASON: Product may not be tensioned properly, potentially causing unexpected rotation or descent.PRODUCT: Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789. Intended use is to deliver x-ray radiation for therapeutic treatment of cancer. Recall # Z-0857-2009.
MANUFACTURER: Siemens Medical Solutions,

REASON: Under certain conditions, the flat panel may move unexpectedly and collide with the patient.PRODUCT: RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Catalog numbers/UPN numbers 21840/M004 218400. Indicated for use in cardiac ablation procedures. Recall # Z-0858-2009
MANUFACTURER: Recalling Firm: Boston Scientific, Corp., San Jose, CA, by letters dated November 26, 2008.Manufacturer: Altech, Corp., Flemington, NJ. Firm initiated recall is ongoing.
REASON: Product malfunction may result in delivery of energy without depressing the foot switch that controls delivery.

PRODUCT: Triathlon PKR Insert X3 #1 LM/RL - 8mm, Catalog number: 5630-G-108; Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122. Intended Use: - Moderately disabling joint disease of the knee resulting from painful osteo or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis - As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicted by deficiencies of the femoral condyle/tibia plateau. These components are intended for implantation with bone cement. Recall # Z-0869-2009.
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on November 25, 2008. Firm initiated recall is ongoing

REASON: Label mix-up: lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE.

PRODUCT: Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser, password and a standard PC. Recall # Recall # Z-0870-2009
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated December 12, 2008. Firm initiated recall is ongoing.
REASON: Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an open session and Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation.

PRODUCT:
a) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 55 mm; REF 32-485150. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0873-2009;
b) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm; REF 32-485151. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0874-2009;
c) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 60 mm; REF 32-485152. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0875-2009;
d) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 62.5 mm; REF 32-485153. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0876-2009;
e) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm; REF 32-485154. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0877-2009;
f) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 67.5 mm; REF 32-485155. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0878-2009;
g) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 70 mm; REF 32-485156. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0879-2009;
h) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 75 mm; REF 32-485157. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0880-2009;
i) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 80 mm; REF 32-485158. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0881-2009;
j) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 72.5 mm; REF 32-485159. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide. Recall # Z-0882-2009.
MANUFACTURER: Recalling Firm: Biomet, Inc., Warsaw, IN, by letter dated December 18, 2008. Manufacturer: Symmetry Medical USA, Inc., Warsaw, IN. Firm initiated recall is ongoing.
REASON: Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.

CLASS III
PRODUCT:
a) Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm, sterile, latex free; UPN 500-104, REF M0065001040 and M0065001041. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0487-2009;
b) Boston Scientific Easy Core Biopsy Device, 18 ga. x 15 cm, sterile, latex free; UPN 500-105, REF M0065001050 and M0065001051. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0488-2009;
c) Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free; UPN 500-106, REF M0065001060 and M0065001061. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0489-2009;
d) Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free; UPN 500-107, REF M0065001070 and M0065001071. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0490-2009;
e) Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free; UPN 500-108, REF M0065001080 and M0065001081. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0491-2009;
f) Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free; UPN 500-114, REF M0065001140 and M0065001141. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0492-2009;
g) Boston Scientific TruPath Biopsy Device, 18 ga. x 21 cm, sterile, latex free; UPN 500-115, REF M0065001150 and M0065001151. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0493-2009;
h) Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free; UPN 1213, REF M00512130 and M00512131. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0494-2009;
i) Boston Scientific Easy Core Biopsy System, 18 ga. x 15 cm, sterile, latex free; UPN 1215, REF M00512150 and M00512151. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate. Recall # Z-0495-2009.
MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letter dated October 17, 2008. Firm initiated recall is ongoing.
REASON: The devices may experience difficulty cocking and arming, resulting in an inability to use the devices.

PRODUCT: Custom Waste Management Kit, K10-01756/B, Sterile EO, Recall # Z-0578-2009.
MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by telephone, fax or visit between September 15, 2008 and October 9, 2008. Firm initiated recall is complete.
REASON: Leak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak.

PRODUCT: BDD l ml Integra TB Syringe with Retracting Precision Glide Needle: 1 ml 27 g ½ (0.4 mm x 13 mm); Sterile; REF # 305298. Made in USA. Syringes for use in aspiration and injection of medications. Recall # Z-0619-2009.
MANUFACTURER: Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letters on November 24, 2008. Manufacturer: BD Medical, Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing.
REASON: Expiry date on the shelf carton is incorrect. It reads 2013-13; it should read 2013-03

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of January 14, 2009:

CLASS II
PRODUCT: GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment, Recall # Z-0285-2009
MANUFACTURER: Recalling Firm: GE Healthcare, Wauwatose, WI, by letter dated August 26, 2008. Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON: A software error has been discovered when using Combination Monitoring with Solar 8000M/I – PDM – Telemetry in combo mode. This error has only been noted with this particular configuration and mode of monitoring.

PRODUCT:
a) Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles, Recall # Z-0320-2009;
b) Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles, Recall # Z-0321-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on September 3, 2008. Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON: Software error – does not allow protocol to properly synchronize with ECG triggers

PRODUCT: FS-OMNI, Fusion Omni-Tome, Sterile, Rx only. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy, Recall # Z-0325-2009
MANUFACTURER: Cook Endoscopy, Winston Salem, NC, by email on October 30, 20008. Firm initiated recall is ongoing.
REASON: The wire control port may have been omitted during manufacture.

PRODUCT: ThomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy, Recall # Z-0339-2009
MANUFACTURER: TomoTherapy, Inc., Madison, WI, by letter dated September 17, 2008. Firm initiated recall is ongoing.
REASON: Treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit inaccuracies with the DVH curve and the Dose Statistics for the small structures. The error can result in up to 30% inaccuracy in the DVH curve and Dose Statistics.

PRODUCT: a) GE OEC 9900 Elite ESP fluoroscopic x-ray system. The system is intended to provide an x-ray display of human anatomy, Recall # Z-0341-2009;b) GE OEC 9900 Elite GSP fluoroscopic x-ray system. The system is intended to provide an x-ray display of human anatomy, Recall # Z-0342-2009
MANUFACTURER: OEC Medical Systems, Inc., Salt Lake City, UT, by letter on August 29, 2008. Firm initiated recall is ongoing.
REASON: Under certain conditions, x-ray system may experience operational impairment.

PRODUCT a) SteriLyte® Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L). This product is used in conjunction with C-Series RenalPure® Liquid Acid Concentrate or DC-Series Dri-Sate® Dry Acid Concentrate in artificial kidney (hemodialysis) machines, Recall # Z-0439-2009;b) SteriLyte® Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L). This product is used in conjunction with C-Series RenalPure® Liquid Acid Concentrate or DC-Series Dri-Sate® Dry Acid Concentrate in artificial kidney (hemodialysis) machines, Recall # Z-0440-2009
MANUFACTURER: Rockwell Medical Technologies, Inc., Grapevine, TX, by fax and/or email on September 29, 2008 and by letter on September 30, 2008. Firm initiated recall is ongoing.
REASON: Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.

PRODUCT:
Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name a) Catch, the label reads "CATCH Catch Inc., HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test Kit, The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1 HCY A (28mL), Homocysteine Reagent R2 HCY R2 (13.5 mL), Homocysteine HCY C (2.8 mL), Homocysteine 0.0 umol/L (2mL) and Homocysteine 27.0 umol/L (2mL).
b) The second brand name Equal the label reads "EQual DIAGNOSTICS FOR IN VITRO DIAGNOSTIC USE ONLY HOMOCYSTEINE 3-Part Kit w/calibrators, Catalog Number E02-058-03, The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1, Homocysteine Reagent R2, Homocysteine Reagent R3, Homocysteine Calibrator 0.0 umol/L and Homocysteine Calibrator 27.0 umol/L. All individual kits are packaged into individual boxes and then packaged into 1 box. Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in serum and plasma, Recall # Z-0448-2009
MANUFACTURER: Recalling Firm: Catch, Inc., Bothell, WA, by letter on January 18, 2007. Manufacturer: Intersect Systems, Inc., Longview, WA. Firm initiated recall is ongoing.
REASON: A high homocysteine level can be reported as falsely low.

PRODUCT:
a)  Angiotech, Bone Marrow Aspiration Needle. The device is intended for use during Bone Marrow Biopsy, Recall # Z-0450-2009;
b) Angiotech, Bone Marrow Biopsy Needle. The device is intended for use during Bone Marrow Biopsy, Recall # Z-0451-2009;
c) Angiotech, T-Lok Bone Marrow Biopsy Needle. The device is intended for use during Bone Marrow Biopsy, Recall # Z-0452-2009;
d) Angiotech, Bone Marrow Harvest Needle. The device is intended for use Bone Marrow Biopsy, Recall # Z-0453-2009
MANUFACTURER: Medical Device Technologies, Inc., Gainesville, FL, by letter on July 16, 2008. Firm initiated recall is ongoing.
REASON: Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.

PRODUCT: Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2, Recall # Z-0455-2009
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on July 23, 2007. Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is complete.
REASON: Software error: The CXP User documentation does not adequately characterize the use of the Live Gate feature.

PRODUCT: Sinu-Lift(TM) System, LLC., Model SLS-1, Sterile, Innovative Implant Technology, The Sinu-Lift(TM) System is intended to: - Facilitate access to the maxillary sinus, - Lift the sinus membrane from the alveolar ridge of the maxilla with a minimum height of 5mm, and - Augment the space created by lifting the maxillary sinus membrane with bone graft to supplement the maxillary alveolar crest with additional height needed for anchoring an implant, Recall # Z-0505-2009
MANUFACTURER: Recalling Firm:  Innovative Implant Technology, Weston, FL, by letter dated September 30, 2008. Manufacturer: Sequel Special Products, LLC, Waterbury, CT. Firm initiated recall is ongoing.
REASON: Possible device failure: The cutter's shaft of the Sinu-Drill of the Sinu-Lift System could potentially get stuck inside the tap, thereby not allowing the cutter to spring out of the tap upon encountering the sinus membrane, increasing the possibility of perforating the sinus membrane.

PRODUCT:
a) Compress Instrument Anchor Plug Holder, stainless steel, REF 32-481006. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery, Recall # Z-0517-2009;
b) Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN; REF 32-481091. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery, Recall # Z-0518-2009;
c) Compress/Finn Instrument Set Compress Anchor Plug Assembly, stainless steel; REF RD425032. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery, Recall # Z-0519-2009;
d) Compress Short Instruments Anchor Plug Holder, 12mm, stainless steel, non-sterile; REF CP460193. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery, Z-0520-2009;
e) Compress Short Anchor Plug Holder, 13mm; REF CP461038. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery, Z-0521-2009 
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated July 18, 2008. Firm initiated recall is ongoing.
REASON: The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.

PRODUCT: Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems; Catalog no. 04522320190. Product is an in vitro diagnostic, Recall # Z-0542-2009
MANUFACTURER: Recalling Firm: Roche Diagnostics, Corp., Indianapolis, IN, by letter dated September 15, 2008. Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
REASON: Test results, low: Sodium, potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward drift in controls and patient samples within the recommended calibration interval of 24 hours.

PRODUCT: Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number 5526-B-500, Cementless use only. Sterile. Made in Ireland. The Triathlon Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function, Recall # Z-0579-2009
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on September 20, 2006. Manufacturer: Howmedica International S de RL, Limerick, Ireland. Firm initiated recall is complete.
REASON: One lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating.

PRODUCT:
a) Synergy Pulse, Powered Flotation Therapy bed, Model number 5609. Designed to provide enhanced static and pulsation pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing pulsation therapy, Recall # Z-0600-2009;
b) Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing alternating pressure therapy and lateral rotation up to 45 degrees side to side, Recall # Z-0601-2009;
c) Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle, Recall # Z-0602-2009;
d) Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies, Recall # Z-0603-2009
MANUFACTURER: Hill-Rom Manufacturing, Inc., Charleston, SC, by letter on or about October 31, 2008. Firm initiated recall is ongoing.
REASON: The devices have the potential to overheat.

PRODUCT: Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician and is intended for general purpose CT applications, Recall # Z-0608-2009
MANUFACTURER: Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letters on November 5, 2008. Manufacturer: Hitachi Medical Corp., Tokyo, Japan. Firm initiated recall is ongoing.
REASON: Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).

PRODUCT: ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Model: CVi Toshiba interface Cable, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection system supplies radiopaque contrast media to a catheter at a user-determined variable flow rate and volume which can be instantaneously and continuously varied. The ACIST CVi injection system is able to synchronize with certain X-ray imaging systems from Siemens, Toshiba, GE and Philips. Intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures, Recall # Z-0643-2009
MANUFACTURER: Acist Medical Systems, Eden Prairie, MN, by letter dated November 10, 2008. Firm initiated recall is ongoing.
REASON: Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in multiple injections of contract media when one injection was intended.

PRODUCT: CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System, Recall # Z-0647-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated October 8, 2008. Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON: Indicated orientation does not match actual orientation of the patient.

PRODUCT: High-low:x frame for the x:panda mechanical chair, Recall # Z-0651-2009
MANUFACTURER: Recalling Firm: Snug Seat, Inc., Stallings, NC, by letter dated November 6, 2008 and by visit on November 18, 2008. Manufacturer: R82 A/S, Gedved, Denmark. Firm initiated recall is ongoing.
REASON: Breakage in the welds was discovered in a section of the chair frame.

PRODUCT: Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection, Recall # Z-0607-2009
MANUFACTURER: Diamedix Corp., Miami, FL, by letter on October 10, 2008. Firm initiated recall is ongoing.
REASON: Possible false-negative test results

PRODUCT: Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile; REF 6420-01-230. The modular cemented tibial baseplate is indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. These are single use implantable devices sold sterile, Recall # Z-0871-2009
MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated November 25, 2008. Firm initiated recall is ongoing.
REASON: Sterility compromised: Lack of assurance of sterility, as a corner flap of the sterile barrier packaging on the inner cavity may be trapped in the seal of the barrier packaging for the outer cavity and the seal integrity of the outer sterile barrier cannot be assured.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of January 7, 2009:

CLASS II
PRODUCT: GE Centricity Ultra Laboratory System Software for recording, reporting and distribution of lab results, Recall # Z-0472-2009
MANUFACTURER: Recalling Firm: GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated September 19, 2008. Manufacturer: Triple G Systems Group, Inc., Markham, Canada. Firm initiated recall is ongoing.
REASON: Software computer error: The abnormal result flag is not being sent in the HL7 messages on results that are lower than the normal range.

PRODUCT:
a) Siemens KinetDx 4.2 Workplace, 10090235. Indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information, Recall # Z-0543-2009;
b) Siemens syngo Dynamics Workplace, version 5.0. Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation, Recall # Z-0544-2009;
c) Siemens syngo Dynamics Workplace, version 6.0. Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation, Recall # Z-0545-2009
MANUFACTURER: Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by letter dated July 23, 2008. Firm initiated recall is ongoing.
REASON: If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.

PRODUCT:
a) Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems, Recall # Z-0507-2009;
b) Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers: 64753-126. Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems, Recall # Z-0508-2009
MANUFACTURER: Alphatec Spine, Inc., Carlsbad, CA, by telephone October 21, 2008. Firm initiated recall is complete.
REASON: Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the following lot numbers: Part Number 64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.

PRODUCT: MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular. Intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurovascular, Peripheral Vascular and Coronary Vascular systems and for superselective angiography of peripheral and coronary vasculature, Recall # Z-0604-2009
MANUFACTURER: Cordis Corp., Miami Lakes, FL, by letter dated June 30, 2008. Firm initiated recall is complete.
REASON: Two lots have the potential for sterile PTFE contamination within the inner lumen of the catheter.

PRODUCT: Stryker Leibinger New Generation/Universal Mandibular System, Mandibular Recon Plate, Straight, w. Template; REF # 55-28911. A mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and reconstruction, Recall # Z-0610-2009
MANUFACTURER: Recalling Firm: Stryker Leibinger USA, Portage, MI, by letter dated September 2008. Manufacturer: Stryker Leibinger Gmbh, Freiburg, Germany. Firm initiated recall is ongoing.
REASON: A template is supposed to accompany the product, but it was not included with this lot.

PRODUCT: DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities. a) Model 515ADS; b) Model 515ADZ; c) Model 515AKS; and d) Model 515AKZ, Recall # Z-0617-2009
MANUFACTURER: Sunrise Medical, Somerset, PA, by telephone beginning October 30, 2008 and by letters dated November 7, 2008. Firm initiated recall is ongoing.
REASON: Potential for sieve beds to have been incorrectly assembled.

PRODUCT: Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1 silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104. Made in USA with imported components "For the fecal management of patients with little or no bowel control and liquid or semi-liquid stool", Recall # Z-0618-2008
MANUFACTURER: Recalling Firm: CovaTec, Skillman, NJ, by letters on November 18, 2008. Manufacturer: Vesta, Inc., Franklin, WI. Firm initiated recall is ongoing.
REASON: A portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device.

PRODUCT:
a) Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure, Recall # Z-0644-2009;
b) CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure, Recall # Z-0645-2009
MANUFACTURER:b Recalling Firm: Edwards Lifesciences Research Medical, Inc., Midvale, UT, by letter on November 26, 2008. Manufacturer: Accellent, Inc., Laconia, NH. Firm initiated recall is ongoing.
REASON: Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure.
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