MEDLINE INDUSTRIES, LP - Northfield: FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. 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: 36 kits Lot/code info: UDI-DI: 10195327050146(each), 40195327050147(case); Lot Number: 23HMB316

UPC codes

10195327050146, 40195327050147

Source

Official record: FDA (Device enforcement) ↗

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