DeRoyal Industries Inc: 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

Hazard

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Details from the source

Reason for recall: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. Distribution: US Nationwide distribution. Quantity: 328 packs Lot/code info: a) REF 89-10640, GTIN 50749756367740 (cs), 00749756367745 (unit), Lot Numbers: 58737945; b) REF 89-10901, GTIN 50749756380244 (cs), 00749756380249 (unit), Lot Numbers: 58820749; c) REF 89-1924, GTIN 50749756216864 (cs), 00749756216869 (unit), Lot Numbers: 58746227; d) REF 89-7133, GTIN 50749756736744 (cs), 00749756736749 (unit), Lot Numbers: 58789323; e) REF 89-9134, GTIN 50749756911332 (cs), 00749756911337 (unit), Lot Numbers: 58701336; f) REF 89-9478, GTIN 50749756926909 (cs), 00749756926904 (unit), Lot Numbers: 58738454

UPC codes

50749756367740, 00749756367745, 50749756380244, 00749756380249, 50749756216864, 00749756216869, 50749756736744, 00749756736749, 50749756911332, 00749756911337, 50749756926909, 00749756926904

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.