MEDLINE INDUSTRIES, LP - Northfield: MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.

Hazard

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

Details from the source

Reason for recall: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods Distribution: US Nationwide. Canada. Quantity: 40 kits Lot/code info: UDI-DI: 10193489288384 (each), 40193489288385 (case); Lot Number: 23AMD730

UPC codes

10193489288384, 40193489288385

Source

Official record: FDA (Device enforcement) ↗

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