Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-8 infusion set; Catalog number 4544773001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accu-Chek Ultraflex-8 infusion set; Catalog number 4544773001.
Brand
Disetronic Medical Systems, Inc.
Lot Codes / Batch Numbers
Lots 31097UF, 3C135UF, 3D001UF, 3E008UF, 3E065UF, 3G012UF, 3G107UF, 3G116UF, 3H040UF, 3H051UF, 3J018UF, 3K035UF, 3K101UF, 3L098UF, 3L122UF, 4A127UF, 4D030UF, 4D032UF, 4D161UF, 4D180UF, 4F020UF, 4F083UF, 4G184UF, 4H101IF, 4K133UF and 4L096UF.
Products Sold
Lots 31097UF, 3C135UF, 3D001UF, 3E008UF, 3E065UF, 3G012UF, 3G107UF, 3G116UF, 3H040UF, 3H051UF, 3J018UF, 3K035UF, 3K101UF, 3L098UF, 3L122UF, 4A127UF, 4D030UF, 4D032UF, 4D161UF, 4D180UF, 4F020UF, 4F083UF, 4G184UF, 4H101IF, 4K133UF and 4L096UF.
Disetronic Medical Systems, Inc. is recalling Accu-Chek Ultraflex-8 infusion set; Catalog number 4544773001. 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