Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270

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: 152 kits Lot/code info: UDI/DI each 10198459322235, UDI/DI case 40198459322236, Lot Numbers: 26AMF231, 25GMC304, 25DMF469.

UPC codes

10198459322235, 40198459322236

Source

Official record: FDA (Device enforcement) ↗

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