MEDLINE INDUSTRIES, LP - Northfield: Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON

Hazard

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Details from the source

Reason for recall: Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. Distribution: Worldwide distribution - US Nationwide and the countries of UAE, and Canada. Quantity: 1072 units Lot/code info: 1) REF DYNJ58648B, UDI/DI 10193489624182 (EA) 40193489624183 (CS), Lot Numbers: 19BDB193; 2) REF DYNJ58648C, UDI/DI 10193489688542 (EA) 40193489688543 (CS), Lot Numbers: 19EDD585, 19IDA770, 20AMA033, 20AMC750, 20EMB449; 3) REF DYNJ66447, UDI/DI 10193489367379 (EA) 40193489367370 (CS), Lot Numbers: 20KMC595, 21AMB129; 4) REF DYNJ58648D, UDI/DI 10195327212124 (EA) 40195327212125 (CS), Lot Numbers: 22KMD675, 23DMD129, 23HMG766, 23JMD938; 5) REF DYNJ58648J, UDI/DI 10193489356793 (EA) 40193489356794 (CS), Lot Numbers: 20EBN856, 20JBG508, 20JBK503, 20JBT975, 20KBQ270, 21ABK829, 21EBP637, 21EBP646, 21JBO555, 21KBC098, 21KBV126, 21LBP144.

UPC codes

10193489624182, 40193489624183, 10193489688542, 40193489688543, 10193489367379, 40193489367370, 10195327212124, 40195327212125, 10193489356793, 40193489356794

Source

Official record: FDA (Device enforcement) ↗

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