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Terminated

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.

FDA Recall Z-0260-05 · Posted 2004-11-30

Recalling FirmGaymar Industries Inc
Recall StatusTerminated
Product CodeIKZ
Date Initiated2004-10-25
Date Terminated2006-02-08
Product Quantity48 units

Reason for Recall

Design control/validation deficiencies.

Firm 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.

Root Cause

Other

Distribution Pattern

The units were sold to the own-label distributor, who in turn sold 8 units to two hospitals in Nebraska and Hawaii.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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