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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK

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  Class 2 Device Recall LIFEPAK see related information
Date Initiated by Firm April 02, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on January 06, 2005
Recall Number Z-0886-04
Recall Event ID 28727
510(K)Number K012428  
Product Classification Automated External Defibrillators (Non-Wearable) - Product Code MKJ
Product LIFEPAK 500 automated external defibrillator
Code Information Part numbers 3005380-000 through 3005380-006 and 3005380-014 Serial numbers may be obtained from the firm or from Seattle District Recall Coordinator.  All battery date codes prior to 0013
Recalling Firm/
Manufacturer		 Medtronic Physio Control Corp
11811 Willows Rd NE
Redmond WA 98073
For Additional Information Contact John A. Parks
425-867-4681
Manufacturer Reason
for Recall		 Potential for batteries to malfunction due to battery cell rupture.
FDA Determined
Cause 2		 Other
Action On 4/2/04 the firm initiated telephone contacts to customers to determine if the customer potentially has suspect battery. If so, the customer will be faxed a letter describing how to remove the battery to check for the code date. If customer confirms they have suspect battery, a new battery will be shipped to customer.
Quantity in Commerce 7028
Distribution The firm distributed devices nationwide to various hospitals, medical centers, and businesses. The firm also distributed to foreign customers in Australia, Argentina, Brazil, Canada, China, Greece, Hong Kong, Israel, India, Jordan, Mexico, Netherlands, New Zealand, Oman, Philippines, Saudi Arabia, United Kingdom.
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 = MKJ and Original Applicant = MEDTRONIC PHYSIO-CONTROL CORP.
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