KCI USA, Inc.

Models 412045-01 & 412046-01. Serial Numbers PRNK00001, PRNK00002, PRNK00003, PRNK00004, PRNK00006, PRNK00007, PRJK00001, PRJK00002, PRXK00001, PRXK00002, and PRXK00003.

General Hospital and Personal Use Devices

1

No

USA Nationwide Distribution including the states of ID and FL

Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 412046-01. || Product Usage: Human Non-AC-Powered Patient Lift

Model Number 208030, Serial Numbers: 00157087, 00157091, 00157288, 00157375, 00157405, RRCKOO011, RRHKOO065, RRHKOO074, RRHKOO096, RRHK00109, and RRHKOO117.

Physical Medicine Devices

2

No

Nationwide Distribution including AL, CA, CO, OK and GA.

RotoRest Delta Kinetic Therapy System || INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction

For M8275063/5: 20064392, 20069119, 20069125, 20069126, 20069279, 20069279.18308F, 20075082, and 20079173  For M8275063/10: 20046268, 20046268.18908A, 20046270, 20063933, 20064393, 20064394, 20064395, 20064753, 20064753.14408B, 20067300, 20067300.14408B, 20067301, 20067302, 20067303, 20067304, 20067305, 20069120, 20069121, 20069273, 20069273.14408B; 20069274, 20069275, 20069275.18908A, 20069277, 20069277.18908A, 20069278, 20069278.18908A, 20069280, 20075084, 20075085, 20075086, 20075262, 20075263, 20075264, 20075265, 20075266, 20075268, 20075269, 20079174, 20079175, 20079176, 20079177, 20079178, 20079179, 20079180, 20079181, 20079182, 20079183, 20079184, 20079185, 20079186, 20079187, 20079188, 20089680, 20089681, 20089682, 20089712, 20089713, 20089749, 20089750, 20093372, 20093374, and 20094200

General and Plastic Surgery Devices

2

No

Worldwide Distribution --- including USA and countries of Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden, and the UK.

500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part #M8275063/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.

For M8275071/5: 20063928   For M8275071/10: 20062500, 20063927, 20063927.15108D, 20063930, 20063930.15108D, 20067296, 20067297, 20067298, 20069122, 20069123, 20069123.15108D, 20069124, 20069124.15108D, 20069276, 20071227, 20073941, 20075083, 20075267, 20079189, 20079190, 20079191, 20089714, and 20094198

General and Plastic Surgery Devices

2

No

Worldwide Distribution --- including USA and countries of Austria, Belgium, Denmark, France, Germany, Netherlands, Sweden, and the UK.

500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M8275071/10 (10 canister pack); products are single use and labeled as STERILE; distributed by Kinetic Concepts, Inc., San Antonio, TX.

Device serial numbers affected: Kinair IV: KAPK00523 - KAPK00691; Kinair IV 60601: KAUK00001 - KAUK00134; Triadyne Proventa: TDDK0001 - TDDK00367; Therapulse ATP: TPNK00001 - TPNK00177; Kinair Medsurg: 1440-1441, KAS01524, KASK01004 - KASK02930; and Kinair Medsurg Pulse: KATK00001 - KATK00655

Physical Medicine Devices

2

No

Nationwide and Canada

AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #4100079 used with Kinair IV Model 22600, Kinair IV 60601 Model 216050, Triadyne Proventa Model 406000, Therapulse ATP/II Models 227800 and 227080.S, Kinair Medsurg Model 201001W, and Kinair Medsurg Pulse Model 40900.