MEDLINE INDUSTRIES, LP - Northfield: SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. 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: 10193489789935(each), 40193489789936(case); Lot Number: 20JBD814

UPC codes

10193489789935, 40193489789936

Source

Official record: FDA (Device enforcement) ↗

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