ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA. 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, Switzerland
FDA Recall Z-1482-2011 · Posted 2011-03-10
Recalling FirmRoche Insulin Delivery Systems Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2011-02-24
Date Terminated2011-07-27
Product Quantity1,454,918 million worldwide
Reason for Recall
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.
Firm 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 fax per the instructions on the card. The letter also lists some additional information pertaining to signs and symptoms. Questions regarding this recall should be directed to ACCU-CHEK Customer Care at 1-800-688-4578, 24 hours a day, 7 days a week.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- US and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.