Serial numbers 0550037 through 0559399.

Physical Medicine Devices

2

No

Nationwide

TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit, manufactured by Kinetic Concepts, Inc.

Rascal Model Numbers 205, 215, 235, 245, 255, 305, 400. There are 45,679 serial numbers.

Physical Medicine Devices

2

No

Distribution is both nationwide and international. The distribution are to retail customers, intercompany sales, and dealers. The Veterans Administration, Canada, United Kingdom.

Rascal Powered Scooters.

Model Numbers: (Lynx) LX-3, SX-3, SX-3P; (Panther) LX-4, MX-4. Serial Numbers: 99J through 00G.

Physical Medicine Devices

2

No

The scooters were shipped to dealerships located nationwide, and to foreign distributors located in Barbados, Argentina, Isreal, and Bermuda.

Invacare Lynx and Panther Scooters, motorized 3-wheeled vehicles.

Product number 14761106, Lot numbers: 53078 and 53985

Physical Medicine Devices

1

No

ID, CA, NC, TX, SC, NM, GA and TN

Flexgard, off-the-shelf knee brace, product number 14761106

Serial Numbers: 1100068 to 1103702

Physical Medicine Devices

2

No

Nationwide, Puerto Rico, Canada

Permobil Chairman 2K powered wheelchair, Model 1280

All Model Numbers (excluding the 2nd generation models); Serial Numbers: 93I through 02E

Physical Medicine Devices

2

No

The scooters were shipped to dealerships located nationwide, and to foreign distributors located in Thailand, So. Africa, Hong Kong, New Zealand, Japan, Maylasia, Korea, Isreal, Australia. 92% of affected units were shipped to domestic accounts.

Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs.

Serial numbers: 1100155 to 1102472 and 4100019 through 4100225.

Physical Medicine Devices

2

No

Nationwide, Canada and Puerto Rico

Permobil Chairman 2K powered wheelchair

LOTS IA702, II327, IK454, IM236

Physical Medicine Devices

1

No

Product was distributed to dealers, independent sales representatives, and distributors around the US and worldwide.

Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS.

Chauffeur Model Numbers are C205, C215, C235, C245, C255, and C305. There are 45,679 serial numbers involved.

Physical Medicine Devices

2

No

Distribution is both nationwide and international. The distribution are to retail customers, intercompany sales, and dealers. The Veterans Administration, Canada, United Kingdom.

Chauffeur Powered Scooters.

No lot numbers apply, there are no serial numbers for this product. All frames manufactured since the product was released are suspect.

Physical Medicine Devices

1

No

Nationwide.

Mauch XG, Caron Knee Frame. || Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.

Model CII, Serial #CC(all numeric codes).

Physical Medicine Devices

2

No

The units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada, Austria, France, Germany Ireland Italy, Netherlands, Spain, Sweden, Switzerland and the United Kingdom.

CLINITRON CII Air Fluidized Therapy unit.

Model: Uplift, Serial #CH(all numeric codes).

Physical Medicine Devices

2

No

The units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada, Austria, France, Germany Ireland Italy, Netherlands, Spain, Sweden, Switzerland and the United Kingdom.

CLINITRON UP-LIFT Air Fluidized Therapy unit.

Lot #250512, Item #489150, 489230, 489267, 489305, 489310, 489347, 489433, 489374, 489412, 489427 and 499448. Lot #250514, Item #489150, 489230 and 489273.

Physical Medicine Devices

1

No

Product was shipped to one distribution center in CA who shipped product to consignees located in CA and NV.

PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double Ply, 6''x 72'', 4''x 48'' and 6''x 48''Single Ply and 4''x 4 YDS, 6''x 4 YDS and 3''x 4YDS, 1/pk 25 pk/cs, Manufactured for: Professional Hospital Supply, 41980 Winchester Rd, Temecula, CA 92590.

Model/Catalogue Nos.: 7950 (120 Volt) and 7952 (220 Volt); Serial Numbers: 6211-6230, 1907 & 1920

Physical Medicine Devices

IL, CA, TX, OH, FL, LA, WA, NC and DC

Triton T-700 Traction Unit,

Model/Catalogue Nos.: 7961 (120 Volt) and 7963 (220 Volt); Serial Numbers: 4231 - 4246, 6806 - 6809, 6815, 6818 ¿ 6819, 6824, 6851, 6856 ¿ 6859, 6863, 6870 ¿ 6873, 6878 ¿ 6919, 6921 ¿ 6958

Physical Medicine Devices

1

No

Nationwide. TX, CO, MD, VA, FL, PA, NJ, NY, IN, OH, MI, MO, AL, NV, IL, CA, NM, AR, LA, NE, WA, NC, A, NH, and OK

Triton MP-1 Traction Unit

Model 206 (CS), Serial numbers 101671 and 103443 510K: K942184

Physical Medicine Devices

2

No

Hill Rom primarily leases these units to home care patients and some are sold nationwide.

Clinitron At Home¿ Air Fluidized Therapy Unit

Model #13000, IBxxxxxx (where xxxxxxx is a 6-digit number sequence)

Physical Medicine Devices

2

No

Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.

FLEXICAIR¿ II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.

MC3, Serial numbers: IC xxxxxx (where xxxxxxx is a 6-digit number sequence).

Physical Medicine Devices

2

No

Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.

FLEXICAIR MC3¿ Low Airloss Therapy unit

All stretchers manufactured between 1/1/1993 and 11/07/2003.

Physical Medicine Devices

2

No

United States, Canada, Hong Kong, Israel, Mexico and Syria.

Stryker brand Model 1550 Synergy Extended Stay Stretcher

Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx, and 02Axxx.

Physical Medicine Devices

2

No

The units were shipped to domestic dealerships located nationwide, and to foreign accounts in Canada, China, Oman, and West Indies.

Invacare 2G Tarsys Seating System, Model 2GTR.

All units.

Physical Medicine Devices

2

No

United States and Colombia.

Stryker brand Synergy extended stay stretcher; model 1050

Drop seat bases are not labeled with serial or code numbers, but are found on all wheelchair cushions labeled as Xact Integrated and Xact Individual w/Drop Seat Base.

Physical Medicine Devices

1

No

Product was sold to medical device dealers, primarily pharmacies, nationwide and internationally.

Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.

The following serial numbers: TDBK00029, TDBK00294, TDBK00015, TDBK00291, TDBK00026, TDBK00027, TDBK00123, TDBK00124, TDBK00125, TDBK00127, TDBK00128, TDBK00130, TDBK00132, TDBK00136

Physical Medicine Devices

2

No

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

KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900

Serial numbers: TPLK00053, TPLK00052, TPLK00011, TPLK00012, TPLK00013, TPLK00014, TPLK00015, TPLK00016, TPLK00124, TPLK00128, TPLK00132

Physical Medicine Devices

2

No

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

KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080

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

Physical Medicine Devices

2

No

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

KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189