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DeRoyal Industries Inc recalls Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-1090
Recalled July 12, 2023 · FDA recall Z-2088-2023 · DeRoyal Industries
Hazard
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. · FDA Class II
Units
328 packs
Sold at
US Nationwide distribution.
Description
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Product
Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
Manufacturer(s)
DeRoyal Industries Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →