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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 25, 2004
Date Posted November 30, 2004
Recall Status1 Terminated 3 on February 08, 2006
Recall Number Z-0260-05
Recall Event ID 30065
Product Classification Bed, Patient Rotation, Powered - Product Code IKZ
Product 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.
Code Information 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.  
Recalling Firm/
Manufacturer		 Gaymar Industries Inc
10 Centre Dr
Orchard Park NY 14127-2280
For Additional Information Contact Chuck Dunlap
800-828-7341 Ext. 644
Manufacturer Reason
for Recall		 Design control/validation deficiencies.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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