Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F

Hazard

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Details from the source

Reason for recall: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. Distribution: Worldwide distribution. Quantity: 340 kits Lot/code info: UDI/DI each 10889942930883, UDI/DI case 40889942930884, Lot Numbers: 21GBA316, 21FBA411, 21DBI004, 21BBS142.

UPC codes

10889942930883, 40889942930884

Source

Official record: FDA (Device enforcement) ↗

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