Date Recall |
March 31, 2006 |
Product: |
Disetronic Accu-Chek™ Ultraflex-1 Infusion Set, Catalog # INF04540786001 |
Use: |
For continuous delivery of short-acting or fast-acting U100 insulin for the treatment of insulin-dependent diabetes mellitus. |
Recalling Firm: |
Roche Diagnostics Corporation |
Reason for Recall: |
Tubing may fully or partially separate at the luer lock-tubing connection of the pump. 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. |
Public Contact: |
Roche Diagnostics Corporation |
FDA District: |
Detroit |
FDA Comments: |
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. |
Consumers with questions may contact the company at 1-(800) 688-4578. A copy of the company’s 4/3/06 press release is available on its Website. http://www.disetronic-usa.com/files/General/Press%20Releases/ACUFXPRFINAL040306.pdf |
Updated July 20, 2006
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