MEDLINE INDUSTRIES, LP - Northfield: Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A

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: 318 kits Lot/code info: UDI-DI: DYNJ21927R, 10195327104733(each), 40195327104734(case); Lot Number: 23IBF547 23GBT501 23FBU360 23EBU929 23EBL624 23EBA114 23CBN730 23ABF393 22JBK203 22IBN858 22HBO301 22GBC794 22CBI774; UDI-DI: DYNJ910120A, 10195327689872 (each), 40195327689873 (case), Lot Numbers: 24HMK254

UPC codes

10195327104733, 40195327104734, 10195327689872, 40195327689873

Source

Official record: FDA (Device enforcement) ↗

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