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U.S. Department of Health and Human Services

Class 2 Device Recall KCI Therapulse II

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  Class 2 Device Recall KCI Therapulse II see related information
Date Initiated by Firm March 22, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 02, 2005
Recall Number Z-0888-04
Recall Event ID 28683
Product Classification Bed, Air Fluidized - Product Code INX
Product KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080
Code Information Serial numbers: TPLK00053, TPLK00052, TPLK00011, TPLK00012, TPLK00013, TPLK00014, TPLK00015, TPLK00016, TPLK00124, TPLK00128, TPLK00132
Recalling Firm/
Manufacturer
Kinetic Concepts, Inc
4958 Stout Dr
San Antonio TX 78219-4334
Manufacturer Reason
for Recall
Battery outgassing of powered hospital beds
FDA Determined
Cause 2
Other
Action The firm initiated the recall via letter on 03/22/2004.
Quantity in Commerce 15 beds
Distribution Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
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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