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.
Recall
- Recall Number
- Z-0260-05
- Event Number
- 30065
- Firm
- Gaymar Industries Inc
- FEI Number
- 1313850
- Product Code
- IKZ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 25, 2004
- Posted
- November 30, 2004
- Terminated
- February 8, 2006
- Address
- 10 Centre Dr, Orchard Park, NY, 14127-2280
Description
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.
Design control/validation deficiencies.
Letter dated 10/25/2004 to Stryker Medical, own-label distributor, with instructions to remove patients from the system and return units to Gaymar.
The units were sold to the own-label distributor, who in turn sold 8 units to two hospitals in Nebraska and Hawaii.
48 units