Nationwide and Australia, Benelux, Canada, Denmark, Finland, France, Germany, Israel, Norway, Sweden, and UAE
Descripción del producto
Electric Wheelchairs: || a) C300 CORPUS II || b) C350 CORPUS II || c) C400 CORPUS II || d) C400 CORPUS II LR || e) C500 CORPUS II || f) C500 CORPUS II LR
AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU
AK, AR, AZ, CA, CT, DC, GA, IL, IN, KY, LA, MD, MI, MN, NC, ND, NJ, MN, NY, OH, OK, OR, PA, PR, TX, VA, and WA AU, BE, DE, FR, GB, IT, KW, LU, NL, NO, AT, SA, SE, CH, ES, ZA, and HU
The affected strollers were sold between August 1, 2002 and September 23, 2003. The affected strollers are those strollers equipped with the trigger-activated tilting mechanism. (The firm''s notification letter has photographs of the trigger-activated tilting mechanism which can be used to identify the devices needing correction.)
The following serial numbers, which represent all units shipped: H40001 thru H40038; and I40001, I40003, I40004, I40005, I40006, I40009, I40012, I40013, I40014, I40017, I40018, and I40021.
The units were sold to the own-label distributor, who in turn sold 8 units to two hospitals in Nebraska and Hawaii.
Descripción del producto
XPRT Therapy Mattress Systems: || Model # 2950-000-000 with Dartex urethane-coated nylon cover (deluxe cover); and Model # 2950-000-001 with nylon cover without coating (standard cover). || Responsible firm on the label: Manufactured for STRYKER MEDICAL, 6300 South Sprinkle Road, Kalamazoo, MI USA 49001-9799, 1-800-327-0770. || The unit consists of a sleep surface, an integrated valve box located in the head of the mattress, a pump box located under the foot of the mattress and a color touch screen controller that can be mounted to either side of the pump box at the foot end of the mattress.
Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.
NX Workstation Software is sold in the following packages: 60+0026406, 60+00026407, 60+00026408, 60+00026857, 60+00026858, 60+00026410, ES885. Software versions: NX 1.0.2402 and NX 1.0.2405
Gebauer's Fluro-Ethyl¿ Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. || Gebauer's Fluro-Ethyl¿ is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.
Worldwide Distribution including USA and countries of Spain and Great Britain.
Descripción del producto
Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877. || The product is used as a hip strap chair for children.
Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. || Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components.
Product was distributed to the following states: AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, NC, ND, NM, NY, OH, SC & TX. Product was also distributed in Canada.
Descripción del producto
Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD
Worldwide Distribution - USA (all states except Vermont and Nebraska) and the countries of Belgium, Canada, Chile, Ireland, Kuwait, Netherlands, Saud Arabia, Singapore and United Arab Emirates.
Descripción del producto
Recalled chairs include the following: || 2008 Model Numbers: || 653N - Care Cliner, 654N - XL Care Cliner, 655N - Drop Arm Care Cliner, 657N - XL Drop Arm Care Cliner, 690N - Elite Care Cliner, || 691N - XL Elite Care Cliner, 694N - Dual Swing-Arm Elite Care Cliner, 695N - XL Dual Swing-Arm Elite Care Cliner. || 2009 Model Numbers: || 6530 - Care Cliner, 6540 - XL Care Cliner, 6550 - Drop Arm Care Cliner, 6570- XL Drop Arm Care Cliner, 6900 - Elite Care Cliner, 6910 - XL Elite Care Cliner, 6940 - Dual Swing-Arm Elite Care Cliner, 6950 - XL Dual Swing-Arm Elite Care Cliner.
Worldwide Distribution - USA Nationwide, United Kingdom, Germany, and Saudi Arabia
Descripción del producto
RotoProne Therapy System, Model 209500, Device List Number E232632 || Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.
Invacare TDX series and Storm Series power wheelchairs with 20”-24” width configurations with Formula CG Recline seating system (i.e. Tilt/Recline, Tilt/Recline/Elevate, or Recline only) and a conventional style backModels:TDX Series: TDXSP, TDXSP-AUS, TDX SR-AUS & TDX SRStorm Series: 3GTQ-MCG, STORM TORQUE, STORM TORQUE-AUS, RANGERX, 3GRX-CG, ARROW 3G & 3GAR-TSMultiple serial numbersManufactured from October 1, 2006 - July 31, 2014ARTG number: 160385