Recall Z-1117-06 ยท LZG Pump, Infusion, Insulin
Disetronic Medical Systems, Inc.
Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed outside the U.S. only).
| Date | Jul 8, 2006 (initiated Mar 31, 2006) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Other |
| Action | "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. |
| Quantity | 564,310 in US and Canada plus 11,800 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, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033892 | ULTRAFLEX INFUSION SET Disetronic Medical Systems AG, Mar 9, 2004 |