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U.S. Department of Health and Human Services

Class 2 Device Recall BariMaxx II bariatric bed

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 Class 2 Device Recall BariMaxx II bariatric bedsee related information
Date Initiated by FirmAugust 16, 2004
Date PostedNovember 08, 2005
Recall Status1 Terminated 3 on November 08, 2005
Recall NumberZ-0129-06
Recall Event ID 33679
Product Classification Bed, Ac-Powered Adjustable Hospital - Product Code FNL
ProductBari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O. Box 659508, San Antonio, Texas 78265-9508, Call Toll Free 1-800-531-5346, FAX (210) 308-3998, Http://www.kci1.com
Code Information Product Code 80 FNL, BariMaxx II Serial numbers: BKOk00006 through BKOK00100
Recalling Firm/
Manufacturer		 Kinetic Concepts, Inc
4958 Stout Dr
San Antonio TX 78219-4334
Manufacturer Reason
for Recall		Design change to uppgrade reliability of powered adjustable bed.
FDA Determined
Cause 2		Other
ActionAll consignees were notified with a technical bulletin explaining the inspection and addition of washers to the set-screws.
Quantity in Commerce93 beds
DistributionNationwide
Total Product Life CycleTPLC 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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