FDAClass IIJuly 25, 2012

Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK recall

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

Why was Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04; Lot 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, REF 89-6664.03; Lot numbers: 22924204, 23623163, 23880637, 24076691, 24162522, 24295421, 24585728, 24600836, 24900118, 25030484, 25144351, 25461743, 25559311, 26021993, 26064301, 27526328, 28262740

Product
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
Recalling firm
DeRoyal Industries Inc
Quantity
303 units
Distribution
Nationwide Distribution including SD and NE.
Recall date
July 25, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls