Recall Z-1484-2011 ยท FRN Pump, Infusion
Roche Insulin Delivery Systems Inc.
ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510988001. AC FLEXLINK PLUS SET 6/70 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany Manufactured for and Distributed by Roche Insulin Delivery Systems Inc. Fishers, IN 46037, USA Toll Free: 1-800-280-7801 Roche Diabetes Care AG 3401 Burgdorf, Switzer
| Date | Mar 10, 2011 (initiated Feb 24, 2011) |
| Status | Terminated |
| Reason | There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels. |
| Root cause | Device Design |
| Action | Roche Insulin Delivery Systems sent urgent Product Recall letters, dated 2/21/2011. The letter identified the affected product and described the issue regarding kinked or bent cannulas. The firm requests that customers discontinue use of the ACCU-CHEK FlexLink Plus infusion set and return the unused stock. Customers are to contact their health care provider to determine if changes to their pump therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set. The attached Customer Reply Card should be completed and return via mail or |
| Quantity | 1,454,918 million worldwide |
| Distribution | Worldwide Distribution -- US and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100704 | ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE Disetronic Medical Systems AG, May 14, 2010 |