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.
This recall has been terminated (originally issued November 30, 2004).
- Company
- Gaymar Industries Inc
- Recall Initiated
- October 25, 2004
- Posted
- November 30, 2004
- Terminated
- February 8, 2006
- Recall Number
- Z-0260-05
- Quantity
- 48 units
- Firm Location
- Orchard Park, NY
- Official Source
- View on FDA website ↗
Reason for Recall
Design control/validation deficiencies.
Distribution
The units were sold to the own-label distributor, who in turn sold 8 units to two hospitals in Nebraska and Hawaii.
Lot / Code Info
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.
Root Cause
Other
Action Taken
Letter dated 10/25/2004 to Stryker Medical, own-label distributor, with instructions to remove patients from the system and return units to Gaymar.