Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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: 3684 units Lot/code info: 1) REF DYNJ39461J, UDI/DI 10195327112721 (EA) 40195327112722 (CS), Lot Numbers: 22BBZ954, 22FBB472, 22GBS127, 22HBJ021, 22IBN757, 22LBN387, 22LBP618, 23BBL804, 23FBL965, 23HBG346, 23IBV491, 23JBW568, 24ABJ924, 24CBG585, 24DBM211, 24FBN899, 24FBQ913, 24HBL252, 24HBV561; 2) REF DYNJ80200B, UDI/DI 10195327213978 (EA) 40195327213979 (CS), Lot Numbers: 22HBG124, 22IBJ978, 22JBL067, 22LBQ534, 23ABM279, 23BBR168, 23DBB055, 23EBV555, 23GBB476, 23IBF093, 23KBT109, 24ABA171, 24CBB183, 24DBM493, 24GBB326, 24HBB911.
10195327112721, 40195327112722, 10195327213978, 40195327213979
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.