| | Class 2 Device Recall Burke Bariatric Bed |  |
| Date Initiated by Firm | March 22, 2004 |
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| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on November 02, 2005 |
| Recall Number | Z-0889-04 |
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| Recall Event ID |
28683 |
| Product Classification |
Bed, Ac-Powered Adjustable Hospital - Product Code FNL
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| Product | Burke Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX, model number 7064 |
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| Code Information |
Serial numbers: B7A94031025, B7A94031024, B7A94031023, 000000093101003, 000000093101005, B7A94031010, B7A94031011, B7A94031012, B7A94031013, B7A94031014, B7A94031015, B7A94031030, B7A94031031, B7A94031032, 0498107/335AGJ |
Recalling Firm/
Manufacturer |
Kinetic Concepts, Inc
4958 Stout Dr
San Antonio TX 78219-4334
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Manufacturer Reason
for Recall | Battery outgassing of powered hospital beds |
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FDA Determined
Cause 2 | Other |
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| Action | The firm initiated the recall via letter on 03/22/2004. |
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| Quantity in Commerce | 15 beds |
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| 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 |
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| Total Product Life Cycle | TPLC Device Report |
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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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