Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Numbe

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: 52699 kits Lot/code info: 1) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 2) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 3) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14039 ; 4) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14039 ; 5) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14813 ; 6) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 7) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 8) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 9) PN36NBCH4, UDI-DI: 10198956129863(each), 50198956129861(case), Lot Number: 14813 ; 10) PN36NBCH5, UDI-DI: 10198956131538(each), 50198956131536(case), Lot Number: 14813 ; 11) PN41ACLA9, UDI-DI: 10197106346105(each), 50197106346103(case), Lot Number: 4869 ; 12) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 4366 ; 13) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 4366 ; 14) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 1726-1 ; 15) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 1726-1 ; 16) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 3024 ; 17) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 3916-1 ; 18) PN41ACLAI, UDI-DI: 1019

UPC codes

10198956187474, 50198956187472, 10198956129863, 50198956129861, 10198956131538, 50198956131536, 10197106346105, 50197106346103, 10195594177300, 50195594177308, 10197106320815, 50197106320813, 10197106987032, 50197106987030, 10198956028685, 50198956028683, 10198956062870, 50198956062878, 10888439949698, 50888439949696, 10197106169964, 50197106169962, 10198956072039, 50198956072037, 10198956136502, 50198956136500, 10198956138087, 50198956138085, 10198956143494, 50198956143492, 10198956166189, 50198956166187, 10198956170780, 50198956170788, 10198956183049, 50198956183047, 10198956189867, 50198956189865, 10198956160682, 50198956160680

Source

Official record: FDA (Device enforcement) ↗

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