MEDLINE INDUSTRIES, LP - Northfield: Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRAN

Hazard

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

Details from the source

Reason for recall: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods Distribution: US Nationwide. Canada. Quantity: 22,970 kits Lot/code info: UDI-DI: CDS780045N, 10193489355406 (each), 40193489355407 (case), Lot Numbers: 22JBI816 22JBI817; UDI-DI: CDS780119U, 10193489371116 (each), 40193489371117 (case), Lot Numbers: 22CBL018 21KBV760 21KBV761 21IBV579 21HBB379 21CBC828 21ABJ206 20JBX601 20HBC289; UDI-DI: CDS780119V, 10195327114916 (each), 40195327114917 (case), Lot Numbers: 22FBU189 22DBN874; UDI-DI: CDS981753K, 10193489848946 (each), 40193489848947 (case), Lot Numbers: 22DLA844; UDI-DI: CDS981923X, 10195327434298 (each), 40195327434299 (case), Lot Numbers: 23HBS882; UDI-DI: CDS982719Q, 10193489634853 (each), 40193489634854 (case), Lot Numbers: 20LBD073 20KBE409 20IBD650 20IBE719 20GBT868 20EBI282; UDI-DI: CDS982719R, 10193489441031 (each), 40193489441032 (case), Lot Numbers: 22CBD762 22CBD763 21LBG182 21IBU365 21DBU895 21CBA765 21BBN538; UDI-DI: CDS982719S, 10195327148348 (each), 40195327148349 (case), Lot Numbers: 22GBX154 22GBX157 22FBN679; UDI-DI: CDS982719T, 10195327264161 (each), 40195327264162 (case), Lot Numbers: 23CBO275 23BBG742 23ABP314 23ABQ860 22KBQ362 22JBR890; UDI-DI: CDS982719U, 10195327359676 (each), 40195327359677 (case), Lot Numbers: 23GBO912 23FBP663; UDI-DI: CDS982719V, 10195327510831 (each), 40195327510832 (case), Lot Numbers: 24BBI145 24BBC547 24ABB119 23LBN381 23KBP461; UDI-DI: CDS982719W, 10195327645090 (each), 40195327645091 (case), Lot Numbers: 24DBS813; UDI-DI: CDS984074I, 10193489539240 (each), 40193489539241 (case), Lot Numbers: 22FBW145 22FBW156 22EBN997 22CBP097 21LBX349 21KBB576 21

UPC codes

10193489355406, 40193489355407, 10193489371116, 40193489371117, 10195327114916, 40195327114917, 10193489848946, 40193489848947, 10195327434298, 40195327434299, 10193489634853, 40193489634854, 10193489441031, 40193489441032, 10195327148348, 40195327148349, 10195327264161, 40195327264162, 10195327359676, 40195327359677, 10195327510831, 40195327510832, 10195327645090, 40195327645091, 10193489539240, 40193489539241, 10193489805789, 40193489805780, 10193489939828, 40193489939829, 10193489478358, 40193489478359, 10195327241032, 40195327241033, 10193489801170, 40193489801171, 10193489801163, 40193489801164, 10195327404598, 40195327404599

Source

Official record: FDA (Device enforcement) ↗

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