Z-0887-04
KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas...
KCI USA, Inc. / initiated 2004-03-22 / Terminated
Kinetic Concepts, Inc began a recall of KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900 on . The reason FDA records is "Battery outgassing of powered hospital beds". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0887-04
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- KCI USA, Inc.
- Product
- KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900
- Product code
- IKZ Bed, Patient Rotation, Powered
- Reason for recall
- Battery outgassing of powered hospital beds
- FDA root cause
- 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
- Product codes and lots
- The following serial numbers: TDBK00029, TDBK00294, TDBK00015, TDBK00291, TDBK00026, TDBK00027, TDBK00123, TDBK00124, TDBK00125, TDBK00127, TDBK00128, TDBK00130, TDBK00132, TDBK00136
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
