FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redmond, WA USA. Batteries are Nic
FDA device recall Z-1567-2008 · posted 2008-08-24 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries.
- Action taken
- On February 27, 2008, the firm sent a "URGENT MEDICAL DEVICE - ACCESSORY RECALL" letter via certified return receipt to their consignees. The letter states the batteries are fully functional 1.0 amp/hour batteries mislabeled as 2.4 amp/hour batteries and that the batteries will provide half the monitoring time and half the number of defibrillation shock as of a 2.4 amp/hour LIFEPAK NiCd battery. Enclosed with the letter is a confirmation sheet for the consignee to indicate the number of recalled batteries they have and fax back to the firm. The firm will send out replacement batteries and the consignee is to then send back the mislabeled batteries. If there are any questions, contact the technical support group at 1-800-442-1142 - option 5 or visit www.physio-control-notices.come/fastpak.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 811 batteries
- Distribution
- Batteries were distributed nationwide and to Canada, Netherlands, Asia Pacific and Latin America.
- Date initiated
- 2008-02-27
- Date posted
- 2008-08-24
- Date terminated
- 2011-03-07
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFE PAK 12 (K973486) | Physio-Control Corp. | 1998-01-09 |
| LIFEPAK 11 (K951593) | Physio-Control Corp. | 1995-12-29 |
| LIFEPAK 10 DEFIBRILLATOR/MONITOR (K890079) | Physio-Control Corp. | 1989-02-23 |