MEDLINE INDUSTRIES, LP - Northfield: Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ219

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. Lot/code info: UDI-DI: CDS982719X, 10198459064531 (each), 40198459064532 (case), Lot Numbers: 24IBE288; UDI-DI: DYNJ21927Q, 10889942885534 (each), 40889942885535 (case), Lot Numbers: 21LBB957 21KBA966 21IBN569 21GBO771 20KBB297 20JBB045 20IBI973 20HBU423 20HBC730 20EBU633; UDI-DI: DYNJ21927S, 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24GBQ357 24GBK331 24FBF951 24CBV435 24BBN342 24ABW268; UDI-DI: DYNJ61607A, 10193489665734 (each), 40193489665735 (case), Lot Numbers: 22FLB055 22FLA458; UDI-DI: DYNJ66419C, 10198459059353 (each), 40198459059354 (case), Lot Numbers: 24IBG439; UDI-DI: DYNJ69907, 10193489995558 (each), 40193489995559 (case), Lot Numbers: 22EMA026; UDI-DI: DYNJ69907A, 10195327163976 (each), 40195327163977 (case), Lot Numbers: 22FMB386; UDI-DI: DYNJ81934B, 10198459122910 (each), 40198459122911 (case), Lot Numbers: 24IBG522; UDI-DI: DYNJ82007A, 10195327635466 (each), 40195327635467 (case), Lot Numbers: 24IME319 24HMI978 24HMI081 24CMA496; UDI-DI: DYNJ82011A, 10195327635480 (each), 40195327635481 (case), Lot Numbers: 24HMI979 24GMJ808 24GMB190 24FMD601 24EMD223 24BMJ118; UDI-DI: DYNJ84068, 10195327332143 (each), 40195327332144 (case), Lot Numbers: 23HLA314; UDI-DI: DYNJ84496A, 10198459011245 (each), 40198459011246 (case), Lot Numbers: 24HBF172 24FBN697; UDI-DI: DYNJ85830, 10195327556471 (each), 40195327556472 (case), Lot Numbers: 24IBG585 24DBO636 24BBK513; UDI-DI: DYNJ903566D, 10195327560829 (each), 40195327560820 (case), Lot Numbers: 24BBO346 24BBK920 24ABO451 24ABO

UPC codes

10198459064531, 40198459064532, 10889942885534, 40889942885535, 10195327576233, 40195327576234, 10193489665734, 40193489665735, 10198459059353, 40198459059354, 10193489995558, 40193489995559, 10195327163976, 40195327163977, 10198459122910, 40198459122911, 10195327635466, 40195327635467, 10195327635480, 40195327635481, 10195327332143, 40195327332144, 10198459011245, 40198459011246, 10195327556471, 40195327556472, 10195327560829, 40195327560820, 10195327660420, 40195327660421, 10195327368821, 40195327368822, 10195327618681, 40195327618682, 10198459111723, 40198459111724

Source

Official record: FDA (Device enforcement) ↗

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