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U.S. Department of Health and Human Services

Class 2 Device Recall BariAir

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  Class 2 Device Recall BariAir see related information
Date Initiated by Firm October 21, 1998
Date Posted January 09, 2003
Recall Status1 Terminated 3 on January 28, 2003
Recall Number Z-0414-03
Recall Event ID 25197
510(K)Number K955243  
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
Product KCI BariAir Therapy System; AC-Powered Adjustable Hospital Bed; Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
Code Information All serial numbers of beds produced and distributed to the firm''s service centers at the time of correction.
Recalling Firm/
Manufacturer		 Kinetic Concepts, Inc
4958 Stout Drive
San Antonio TX 78219
Manufacturer Reason
for Recall		 Electrical failure of the bed due to fluid egress into the junction box.
FDA Determined
Cause 2		 Other
Action In an October 21, 1998 e-mail the firm requested return of the product for a planned upgrade. The junction box cover was corrected at the same time of the upgrade.
Quantity in Commerce 144 Beds (6 of which were out of service prior to correction)
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.
510(K) Database 510(K)s with Product Code = FNL and Original Applicant = KINETIC CONCEPTS, INC.
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