FDA-Device2012-07-25Class II
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
DeRoyal Industries Inc
Hazard
Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
Sold states
Nationwide Distribution including SD and NE.
Affected count
303 units
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2008-2012Don't want to check this manually?
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