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
Reported: July 25, 2012 Initiated: June 16, 2012 #Z-2008-2012
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 303 units
- Distribution
- Nationwide Distribution including SD and NE.
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by DeRoyal Industries Inc. Units affected: 303 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2012. Severity: Moderate. Recall number: Z-2008-2012.
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