Reported Jul 25, 2012 · Terminated
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03…
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- Custom surgical kits and trays
GEO-MED TOTAL KNEE PACK PGYBKREF 89-6664.04 GEO-MED TOTAL HIP PACKREF 89-6664.03 surgical kits
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 89-6664.04GEO-MED TOTAL KNEE PACK PGYBK 89-6664.03Lot numbers: 22737521, 22924079, 23427293, 23536123, 24076552, 24435084, 24435084, 24750543, 25088133, 25275511, 25598563, 26476576, 26924324, 26959148, 27264233, 27526176, 27756781, 27756781, 28238361, 28481694 GEO-MED TOTAL HIP PACK — Lot numbers: 22924204, 23623163, 23880637, 24076691, 24162522, 24295421, 24585728, 24600836, 24900118, 25030484, 25144351, 25461743, 25559311, 26021993, 26064301, 27526328, 28262740 - Amount recalled
- 303 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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