510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-2311-2010

External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e...

Physio Control, Inc. / initiated 2008-11-17 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Physio Control, Inc. began a recall of External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor on . The reason FDA records is "Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2311-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Physio Control, Inc.
Product
External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor.
Product code
LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Reason for recall
Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments.
Root cause tag
labeling and UDI
FDA 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 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.
Quantity in commerce
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) .
Product codes and lots
The product does not have serial numbers or lot numbers.   External Sterilizable Paddles used with LIFEPAK 12 and 20/20e Defibrillators have a Part Number 3009166-XX (XX symbolized any 2 numbers).   External Sterilizable Paddles used with LIFEPAK 9 and 9P Defibrillators have a Part Number 804507-XX (XX symbolizes any 2 numbers).