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U.S. Department of Health and Human Services

Class 2 Device Recall Kinetic Concepts

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  Class 2 Device Recall Kinetic Concepts see related information
Date Initiated by Firm April 11, 2000
Date Posted April 18, 2003
Recall Status1 Terminated 3 on December 16, 2003
Recall Number Z-0751-03
Recall Event ID 25452
Product Classification Bed, Flotation Therapy, Powered - Product Code IOQ
Product PediDyne AC-Powered Adjustable Hospital Beds
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Kinetic Concepts, Inc
4958 Stout Drive
San Antonio TX 78219
Manufacturer Reason
for Recall		 Battery Failure/ Outgassing
FDA Determined
Cause 2		 Other
Action Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
Quantity in Commerce 244 units
Distribution Nationwide
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.
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