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Class 2 Device Recall KCI TriaDyne Proventa |
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| Date Initiated by Firm |
March 22, 2004 |
| Date Posted |
July 20, 2004 |
| Recall Status1 |
Terminated 3 on November 02, 2005 |
| Recall Number |
Z-0887-04 |
| Recall Event ID |
28683 |
| Product Classification |
Bed, Patient Rotation, Powered - Product Code IKZ
|
| Product |
KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900 |
| Code Information |
The following serial numbers: TDBK00029, TDBK00294, TDBK00015, TDBK00291, TDBK00026, TDBK00027, TDBK00123, TDBK00124, TDBK00125, TDBK00127, TDBK00128, TDBK00130, TDBK00132, TDBK00136 |
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
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm initiated the recall via letter on 03/22/2004. |
| Quantity in Commerce |
14 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
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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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