MEDLINE INDUSTRIES, LP - Northfield: Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PA

Hazard

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Details from the source

Reason for recall: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. Distribution: Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore. Quantity: 26096 units Lot/code info: a) REF DYNJ902752C, UDI/DI 40195327226993 (case), 10195327226992 (unit), Lot Numbers: 22IBA627, 22JBE922, 22JBP917, 22KBJ447, 23BBB611, 23CBC455, 23EBF908, 23FBV764, 23GBW761, 23IBR157; b) REF DYKE1872A, UDI/DI 40195327330027 (case), 10195327330026 (unit), Lot Numbers: 23CBB846, 23CBK197, 23DBK952, 23FBD020, 23FBG375, 23FBJ258, 23FBV848, 23HBA337, 23HBC022, 23IBA872, 23IBL364, 23JBB228, 23JBE437, 23JBE720, 23JBF969, 23JBV002, 23JBV507, 23KBG556, 23KBM618; c) REF DYKE1921A, UDI/DI 40195327488612 (case), 10195327488611 (unit), Lot Numbers: 23HBQ471, 23JBK197, 23LBD048; d) REF DYNJ901681D, UDI/DI 40193489308090 (case), 10193489308099 (unit), Lot Numbers: 22EBC373, 22EBD234, 22EBE775, 22EBF837, 22FBV877, 22GBT729, 23ABA707, 23BBI384, 23FBO404, 23GBO428, 23GBO470, 23JBH973; e) REF DYKE1922A, UDI/DI 40195327487943 (case), 10195327487942 (unit), Lot Numbers: 23IBK378, 23IBM326, 23JBP210, 23KBX462; f) REF DYNJ905515D, UDI/DI 40193489968041 (case), 10193489968040 (unit), Lot Numbers: 22FMB396, 22FMG767, 22IMB116, 22LMA842, 23AMI823, 23GMH322, 23IMC097; g) REF DYNJ902387K, UDI/DI 40195327505852 (case), 10195327505851 (unit), Lot Numbers: 23JBR461, 23KBT452; h) REF DYNJS2035C, UDI/DI 40193489214278 (case), 10193489214277 (unit), Lot Numbers: 22FDA441, 22GDA574, 22JDB543, 22LDB596, 23ADB285

UPC codes

40195327226993, 10195327226992, 40195327330027, 10195327330026, 40195327488612, 10195327488611, 40193489308090, 10193489308099, 40195327487943, 10195327487942, 40193489968041, 10193489968040, 40195327505852, 10195327505851, 40193489214278, 10193489214277

Source

Official record: FDA (Device enforcement) ↗

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