Recall Z-2311-2010 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Physio Control, Inc.
External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor.
| Date | Aug 28, 2010 (initiated Nov 17, 2008) |
| Status | Terminated |
| Reason | Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments. |
| Root cause | Labeling False and Misleading |
| Action | 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 steril |
| Quantity | 38,185 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, and United Arab Emirates(UAE) . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902288 | MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR Physio-Control Corp., Feb 25, 1991 |