Battery Caps used with Animas IR1250 Insulin Pump. The pump is used to help maintain blood glucose targets.
FDA device recall Z-0294-2009 · posted 2008-11-25 · Terminated
Recall details
- Recalling firm
- Animas Corporation
- Reason for recall
- Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
- Action taken
- The recalling firm issued a notification letter to the patients with insulin pumps on 8/5/08 to inform them of the problem and that they needed to replace the battery. The recalling firm contacted OneTouch Ping users by telephone on 8/5/08 for this issue and another issue. The recalling firm issued letters to distributors informing them of the problem and notified customers to replace the batteries. In addition, a letter was issued to physicians to alert them of the situation with regard to current patients. Consumers can contact 1-800-423-4087 for additional information or questions.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 1,624 units
- Distribution
- Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand,
- Date initiated
- 2008-08-04
- Date posted
- 2008-11-25
- Date terminated
- 2010-02-04
- 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 |