Recall Z-1413-06 ยท LZG Pump, Infusion, Insulin
Disetronic Medical Systems, Inc.
Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.
| Date | Sep 12, 2006 (initiated Jul 13, 2006) |
| Status | Terminated |
| Reason | The battery may turn the pump off without warning due to a design change in the battery. |
| Root cause | Other |
| Action | Press release was issued on 7/13/06. Consignees, distributors and health care providers were issued a recall notice dated 7/13/06 instructing replacement of the power pack every two weeks until further notice. |
| Quantity | 6,604 packs to U.S. and Canada. |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043000 | MODIFICATION TO D-TRONPLUS Disetronic Medical Systems AG, Dec 1, 2004 |