Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number

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: 413 kits Lot/code info: Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 26ABM977; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25KBM387; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25IBG995; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25GBW704; Medline Kit Number/SKU DYNJT3270, UDI/DI each 10198459322235, UDI/DI case 40198459322236, Lot Number: 26AMF231; Medline Kit Number/SKU DYNJT3270, UDI/DI each 10198459322235, UDI/DI case 40198459322236, Lot Number: 25GMC304.

UPC codes

10198459431678, 40198459431679, 10198459322235, 40198459322236

Source

Official record: FDA (Device enforcement) ↗

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