Disetronic Medical Systems, Inc. Accu-Chek FlexLink Cannula 10; Ref number 04541227001. (Distributed outside of the U.S. only). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accu-Chek FlexLink Cannula 10; Ref number 04541227001. (Distributed outside of the U.S. only).
Brand
Disetronic Medical Systems, Inc.
Lot Codes / Batch Numbers
Lots 5A086UF, 5A174UF, 5B125UF, 5C175UF, 5D229UF, 5F009UF, 5F275UF, 5G170UF, 5H078UF, 5H257UF, 5K137UF, 5L146UF and 5L152UF.
Products Sold
Lots 5A086UF, 5A174UF, 5B125UF, 5C175UF, 5D229UF, 5F009UF, 5F275UF, 5G170UF,5H078UF, 5H257UF, 5K137UF, 5L146UF and 5L152UF.
Disetronic Medical Systems, Inc. is recalling Accu-Chek FlexLink Cannula 10; Ref number 04541227001. (Distributed outside of the U.S. only). due to The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyper. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
Recommended Action
Per FDA guidance
"U.S. and International distributors, patients and their physicians were notified via letters dated 3/31/06. Distributors were instructed to search for all part numbers affected by the recall and to provide all affected customers and sub-distributors with the recall notice. Customers were offered a replacement set or replacement with a different model. A press release was also issued on 4/3/06.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026