FDA Device

DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.

Hazard

Custom surgical kits contain Stryker CBCII Blood Conservation Kit which may lack sterility

What You Should Do

Remedy

DeRoyal initiated its recall by visit on 12/09/2009 and followed by letter dated 12/18/2009

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Products

DeRoyal TOTAL KNEE TRACECART, REF 53-1818.13, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.
Brand
DeRoyal Industries Inc
UPC
Lot numbers: 08150012, 08156012, 08172012, 08192012, 08221012, 08247012, 08249012, 08302012, 08270012, 08312012, 08354012, 09022012, and 08354012

Units Affected

194 units

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