Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Ca

Hazard

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Details from the source

Reason for recall: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Distribution: US Nationwide. Canada. Quantity: 87182 kits Lot/code info: 1) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 2) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 3) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 4) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 3747 ; 5) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 4366 ; 6) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 2390 ; 7) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 265098 ; 8) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 7390 ; 9) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 7575 ; 10) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 8160 ; 11) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 12) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 13) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 10339 ; 14) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 15) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 16) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 11020 ; 17) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 10339 ; 18) PE13SPAJC, UDI-DI: 10198956124905(

UPC codes

10195594855130, 50195594855138, 10195594732189, 50195594732187, 10197106290910, 50197106290918, 10198956124905, 50198956124903, 10197106544235, 50197106544233, 10198956163379, 50198956163377, 10197106715765, 50197106715763, 10197106973325, 50197106973323, 10197106997628, 50197106997626, 10198956051201, 50198956051209, 10195594899226, 50195594899224, 10197106904046, 50197106904044, 10197106970300, 50197106970308, 10197106896747, 50197106896745, 10195594886554, 50195594886552, 10195594463182, 50195594463180, 10195594789206, 50195594789204, 10197106815397, 50197106815395, 10198956343863, 50198956343861, 10197106045428, 50197106045426

Source

Official record: FDA (Device enforcement) ↗

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