MEDLINE INDUSTRIES, LP - Northfield: Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.

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: 1494 units Lot/code info: 1) REF DYNJ80585A, UDI/DI 10195327063948 (EA) 40195327063949 (CS), Lot Numbers: 22ABF513, 22DBK159, 22DBL699, 22FBQ597; 2) REF DYNJ80585B, UDI/DI 10195327211158 (EA), 40195327211159 (CS), Lot Numbers: 22GBV101, 22HBG177, 22HBU871, 23ABD760, 23BBE037, 23GBL753, 23GBV443, 23HBU815, 23IBJ525, 23JBO457, 23LBD006, 24BBC495, 24CBI323, 24DBJ068, 24DBP653, 24EBP712, 24FBM276, 24IBG473.

UPC codes

10195327063948, 40195327063949, 10195327211158, 40195327211159

Source

Official record: FDA (Device enforcement) ↗

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