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U.S. Department of Health and Human Services

Class 2 Device Recall TransportAir

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  Class 2 Device Recall TransportAir see related information
Date Initiated by Firm June 01, 1997
Date Posted April 10, 2003
Recall Status1 Terminated 3 on July 08, 2003
Recall Number Z-0718-03
Recall Event ID 25201
Product Classification Bed, Air Fluidized - Product Code INX
Product TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit, manufactured by Kinetic Concepts, Inc.
Code Information Serial numbers 0550037 through 0559399.
Recalling Firm/
Manufacturer		 Kinetic Concepts, Inc
4958 Stout Drive
San Antonio TX 78219
Manufacturer Reason
for Recall		 Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.
FDA Determined
Cause 2		 Other
Action In approximately November 1997 the firm implemented the TransportAir retrograde for all active units.
Quantity in Commerce 4264
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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