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U.S. Department of Health and Human Services

Medical Devices

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Disetronic/Roche Diagnostics Accu-Chek™ Ultraflex-1 Infusion Set

Class 1 Recall
Date Recall
Initiated:
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
9115 Hague Road
Indianapolis, IN 46256-1025

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
9115 Hague Road
Indianapolis, IN 46256-1025
800-688-4578

FDA District:

Detroit

FDA Comments:
  • The company notified patients and their physicians of the problem in letters dated 3/31/06; the FDA subsequently classified this as a Class I recall.
  • Customers deciding to continue using the ACCU-CHEK™ Ultraflex or a replacement ACCU-CHEK™ Ultraflex infusion set, must check their infusion set at the luer lock-tubing connection during use at least every 3 hours and before bedtime.   The replacement ACCU-CHEK Ultraflex infusion sets may still experience this full or partial separation of the luer lock-tubing connection.
  • Patients experiencing the symptoms of hyperglycemia should check to ensure that their blood glucose level is within an acceptable range. Patients may also contact their physician.
  • The symptoms of hyperglycemia include:
    • Nausea/vomiting
    • Blurred vision
    • Excessive thirst or hunger
    • Frequent urination
    • Fatigue/tiredness/sleepiness
    • Headache
    • Fruity acetone breath
    • Abdominal pain

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.