Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG

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: 120 kits Lot/code info: UDI/DI each 10198459237317, UDI/DI case 40198459237318: Lot Numbers: 25LBI308, 25JBH227, 25HBQ371, 25HBP069, 25GBQ494, 25FBM672, 25CBF603, 25BBG224, 25ABN190, 25ABN214.

UPC codes

10198459237317, 40198459237318

Source

Official record: FDA (Device enforcement) ↗

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