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U.S. Department of Health and Human Services

Class 2 Device Recall Internal Sterilizable Paddles and Handles without discharge control

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  Class 2 Device Recall Internal Sterilizable Paddles and Handles without discharge control see related information
Date Initiated by Firm February 16, 2009
Date Posted April 07, 2009
Recall Status1 Terminated 3 on August 17, 2011
Recall Number Z-1171-2009
Recall Event ID 51173
510(K)Number K881153  
Product Classification Low-Energy Dc-Defibrillator (including paddles) - Product Code LDD
Product Internal Sterilizable Paddles (electrodes) and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors.
Code Information Internal Defibrillation Handles without discharge control:  Part Numbers 800441-03 thru 800441-06  Internal Defibrillation Electrodes (threaded end):  Part Numbers: 802154-10 thru 802154-19  Sterilization labeling affects ALL part numbers referenced above.
Recalling Firm/
Manufacturer		 Physio Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact
425-867-4000
Manufacturer Reason
for Recall		 Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.
FDA Determined
Cause 2		 Other
Action Recalling firm sent Urgent Medical Device Recall letters, dated 2/2009, advising customers to discontinue use of the listed sterilization methods and to remove them from service since there is no sterilization method that can be supported by current data. They are to use the enclosed form to identify and confirm if they have the listed products and follow the instructions on the form for returning information to the firm.
Quantity in Commerce TOTAL: 3218 units; 2052 in the US, 1166 internationally
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LDD and Original Applicant = PHYSIO-CONTROL CORP.
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