Recall Z-0260-05 ยท IKZ Bed, Patient Rotation, Powered
Gaymar Industries Inc
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 th
| Date | Nov 30, 2004 (initiated Oct 25, 2004) |
| Status | Terminated |
| Reason | Design control/validation deficiencies. |
| Root cause | Other |
| Action | Letter dated 10/25/2004 to Stryker Medical, own-label distributor, with instructions to remove patients from the system and return units to Gaymar. |
| Quantity | 48 units |
| Distribution | The units were sold to the own-label distributor, who in turn sold 8 units to two hospitals in Nebraska and Hawaii. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.