Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitors.
FDA device recall Z-2312-2010 · posted 2010-08-28 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments.
- Action taken
- On 11/14/08, Physio Control began sending the Urgent User Information letter via certified mail to their customers. The letter notified the customers about the modification to the cleaning and sterilization instruction of the External Sterilization Defibrillation Paddles and Pediatric Paddle attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitors The customers are informed to discontinue use of the gas sterilization methods listed as 12/88 Ethylene Oxide (EO) or 100% Ethylene Oxide (OE). They are notified that they can continue to use the sterilization method such as STERRAD per existing Operating Instructions, but limit sterilization cycles from 100 to 50 cycles. The customers are advised that prior to and after each use, they should examine cables and connector for damage or signs of wear such as loose connections, damaged pins, exposed wires and cable connector corrosion and examine paddles for scratched or pitted surfaces and stop using product if damage has occurred. Within 45 days, the firm will update the Operating Instruction that will include revised Sterilization Guidelines on a website www.physio-control.com/products/product-support. Customers can call Technical Support at 1-800-442-1142, #5 or they can visit the firm's website at www.physio-control-notices.com/extpaddles regarding the recall.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- LDD
- Quantity affected
- 1689 units
- Distribution
- Devices were distributed to medical facilities through out the US and WORLD WIDE to Canada, Germany, India, Netherlands, Australia, Hong Kong, Japan, Brazil, Panama, Russia, Korea, Malaysia, Venezuela
- Date initiated
- 2008-11-17
- Date posted
- 2010-08-28
- Date terminated
- 2010-09-28
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR (K902288) | Physio-Control Corp. | 1991-02-25 |