Animas IR 1250 Insulin Pump.
FDA device recall Z-0929-05 · posted 2005-06-25 · Terminated
Recall details
- Recalling firm
- Animas Corporation
- Reason for recall
- pump failed to respond to keypad button pressess after using the food database feature
- Action taken
- The recalling firm issued a recall notice dated 4/11/05 to all patients and healthcare providers via first class mail. The letter instructs the patient to reset the pump, thus correcting any problems caused by the software bug, and to discontinue use of the food database. All distributors were contacted by phone on 4/12/05 and instructed to return all pumps in their inventory. On 4/25/05, the recalling began emailing and telephoning patients to arrange for replacement and return of the devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 2081 units
- Distribution
- The products were shipped to distributors in FL, TX, UT, and VA. The products were also shipped to patients nationwide.
- Date initiated
- 2005-04-11
- Date posted
- 2005-06-25
- Date terminated
- 2006-01-24
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANIMAS MODEL IR1250 INSULIN INFUSION PUMP (K042873) | Animas Corp. | 2004-12-10 |