Accu-Chek Ultraflex-1 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540883001 (Distributed U.S. and Canada) and
FDA device recall Z-1120-06 · posted 2006-07-08 · Terminated
Recall details
- Recalling firm
- Disetronic Medical Systems, Inc.
- Reason for recall
- 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
- Action taken
- "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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 390,870 in US and Canada plus 10,510 outside N. America
- Distribution
- Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand,
- Date initiated
- 2006-03-31
- Date posted
- 2006-07-08
- Date terminated
- 2007-11-06
- Location
- Fishers, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRAFLEX INFUSION SET (K033892) | Disetronic Medical Systems AG | 2004-03-09 |