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DeRoyal Industries Inc recalls DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE
Recalled November 18, 2015 · FDA recall Z-0240-2016 · DeRoyal Industries
Hazard
Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization. · FDA Class II
Units
355 units
Sold at
SC, FL, OH, NJ, OK, MN, AR
Description
Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.
Product
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; PACEMAKER PACK, REF 89-8381.01;
Manufacturer(s)
DeRoyal Industries Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →