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Manufacturers
Kinetic Concepts, Inc
Manufacturer Address
Kinetic Concepts, Inc, 4958 Stout Dr, San Antonio TX 78219-4334
Source
USFDA
10 Events
Recall of Device Recall KCI TriaDyne Proventa
Recall of Device Recall KCI Therapulse II
Recall of Device Recall Burke Bariatric Bed
Recall of Device Recall KCI
Recall of Device Recall KinAir MedSurg
Recall of Device Recall RotoProne Therapy System
Recall of Device Recall V.A.C. Abdominal Dressing System
Recall of BariMaxx II bariatric bed
Recall of V.A.C.
Recall of V.A.C. ATS Wound Healing System
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10 devices in the database
Device Recall KCI TriaDyne Proventa
Model / Serial
The following serial numbers: TDBK00029, TDBK00294, TDBK00015, TDBK00291, TDBK00026, TDBK00027, TDBK00123, TDBK00124, TDBK00125, TDBK00127, TDBK00128, TDBK00130, TDBK00132, TDBK00136
Product Classification
Physical Medicine Devices
Device Class
2
Implanted device?
No
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 Description
KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900
Device Recall KCI Therapulse II
Model / Serial
Serial numbers: TPLK00053, TPLK00052, TPLK00011, TPLK00012, TPLK00013, TPLK00014, TPLK00015, TPLK00016, TPLK00124, TPLK00128, TPLK00132
Product Classification
Physical Medicine Devices
Device Class
2
Implanted device?
No
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 Description
KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080
Device Recall Burke Bariatric Bed
Model / Serial
Serial numbers: B7A94031025, B7A94031024, B7A94031023, 000000093101003, 000000093101005, B7A94031010, B7A94031011, B7A94031012, B7A94031013, B7A94031014, B7A94031015, B7A94031030, B7A94031031, B7A94031032, 0498107/335AGJ
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
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 Description
Burke Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX, model number 7064
Device Recall KCI
Model / Serial
Serial numbers: IVAK00004, IVAK00023, IVAK00028, IVAK00034, IVAK00033, IVAK00032, IVAK00055, IVAK00060, IVAK00062, IVAK00063, IVAK00030, IVAK50000, IVAK00030, IVAK00035, IVAK00027, IVAK00054, IVAK00037, IVAK00041, IVAK00049, IVAK00044, IVAK00045, IVAK00046, IVAK00047, IVAK00048, IVAK00038, IVAK00039, IVAK00042, IVAK00043, IVAK00051, 000038251, 000038253, 000038295, 000038299
Product Classification
Physical Medicine Devices
Device Class
2
Implanted device?
No
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 Description
KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189
Device Recall KinAir MedSurg
Model / Serial
Serial Numbers KASK00001 through KASK01212
Product Classification
Physical Medicine Devices
Device Class
2
Implanted device?
No
Distribution
The beds were distributed nationwide and to Brazil.
Product Description
KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
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Kinetic Concepts, Inc
Manufacturer Address
Kinetic Concepts, Inc, 4958 Stout Drive, San Antonio TX 78219
Source
USFDA
Language
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