Recall Z-1124-06 ยท LZG Pump, Infusion, Insulin
Disetronic Medical Systems, Inc.
Accu-Chek Ultraflex-2 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540948001.
| Date | Jul 8, 2006 (initiated Mar 31, 2006) |
| Status | Terminated |
| Reason | The luer tube may break at the connection to the pump and, if this is not noticed by the patient, the patient may receive an under delivery of insulin. |
| 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 | 28,170 in US and Canada |
| 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 |