Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPI

Hazard

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Details from the source

Reason for recall: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia. Quantity: 512,786 total units Lot/code info: Catalog Number PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number J34J41 ; Catalog Number PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number J43U77 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J4952G ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J53W73 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J4952H ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J6050F ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J74A27 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J7963D ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J7905F ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J84K02 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J8692Y ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J86T82 ; Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number 20166041-3014 ; Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number 5138318 ; Catalog Number PN33MSOC3, UDI/DI 10197106660881 (EA)50197106660889 (CS), Lot Number 7331471 ; Catalog Number PN33MSOCH, UDI/DI 10197106473498 (EA)50197106473496 (CS), Lot Number 7265882 ; Ca

UPC codes

10888439011371, 50888439011379, 10888439641936, 50888439641934, 10195594235604, 50195594235602, 10197106660881, 50197106660889, 10197106473498, 50197106473496, 10197106586525, 50197106586523, 10195594059576, 50195594059574, 10195594163457, 50195594163455, 10195594576653, 50195594576651, 10887488455440, 50887488455448, 10888439959642, 50888439959640, 10195594239510, 50195594239518, 10197106099384, 50197106099382, 10195594643676, 50195594643674, 10197106012901, 50197106012909, 10197106190494, 50197106190492, 10197106376102, 50197106376100, 10197106375006, 50197106375004, 10197106099377, 50197106099375, 10197106045435, 50197106045433

Source

Official record: FDA (Device enforcement) ↗

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