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April 3rd: Disetronic Medical Systems, Inc. Announces a Voluntary Nationwide Recall of all ACCU-CHEK™ Ultraflex Infusion Sets

Disetronic Medical Systems, Inc, (Disetronic) of Fishers, Ind. announced today a voluntary nationwide recall of all ACCU-CHEK™ Ultraflex Infusion Sets, because of a potential that tubing could fully or partially separate at the luer lock-tubing connection. In the event that a full or partial separation occurs, it is possible that insulin could leak from the infusion set tubing causing an interruption of insulin delivery, which can cause hyperglycemia.

This recall applies to all ACCU-CHEK™ Ultraflex infusion sets. Patients using any standard luer-lock insulin pump may also be using these ACCU-CHEK™ Ultraflex infusion sets. Disetronic is advising customers to check their infusion sets at the luer lock-tubing connection at least every 3 hours and before bedtime.

Disetronic is conducting this recall of ACCU-CHEK Ultraflex infusion sets now, because of a recent increase in complaints regarding fully or partially separated luer lock-tubing connections. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch

For complete FDA report of this update, please refer to following links:
http://www.fda.gov/oc/po/firmrecalls/disetronic04_06.html

If you have comments regarding this update, please email us at info@mdiconsultants.com
 

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