MEDLINE INDUSTRIES, LP - Northfield: Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F

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: 75098 units Lot/code info: a) REF CDS984011C, UDI/DI 40889942325796 (case), 10889942325795 (unit), Lot Numbers: 22EBC452, 22FBX932, 22GBR344, 22HBG632, 22JBR362, 22KBE842, 23EBU748, 23KBF372; b) REF DYKM1184, UDI/DI 40888277877024 (case), 10888277877023 (unit), Lot Numbers: 22FMF770, 22HMF787, 22IMH596, 22KMH402, 22LMG049, 23AMH718, 23BME929, 23BMG061, 23DME554, 23FMI657, 23GMH363, 23IMH597, 23JMB834, 23KMD766; c) REF CDS984010B, UDI/DI 40889942279372 (case), 10889942279371 (unit), Lot Numbers: 22HBM538, 22IBT843, 22KBK453, 23ABM855, 23DBT392, 23KBL270; d) REF DYK1253578F, UDI/DI 40889942925354 (case), 10889942925353 (unit), Lot Numbers: 22FMH475, 22GMD228, 22HMH211, 22HMH348, 22LMC603, 23BMD249, 23DMB067, 23EMJ898, 23FMF457, 23GMG743, 23JME993, 23KMB182, 23LMA953 e) REF DYKE1830, UDI/DI 40195327044207 (case), 10195327044206 (unit), Lot Numbers: 22FLA559, 22GLA591, 22ILA148, 23DLA944, 23ELB067, 23FLA478, 23GLA202, 23GLB207, 23HLA568, 23KLB137; f) REF DYKE1516A, UDI/DI 40889942805748 (case), 10889942805747 (unit), Lot Numbers: 22EBF069, 22FBC759, 22GBW830, 22HBU819, 22IBU640, 22LBC023, 23ABP313, 23BBR036, 23EBF437, 23FBD820, 23GBA762, 23HBK499, 23JBF970, 23KBE276; g) REF DYKM2127, UDI/DI 40195327045013 (case), 10195327045012 (unit), Lot Numbers: 22FLA082, 23KLB138; h) REF DYKE1898, UDI/DI 40195327314713 (case), 10195327314712 (unit), Lot Numbers: 23BBS475, 23EBM141, 23GBJ917, 23IBN380, 23JBB065, 23KBK719; i) REF DYKM2128, UDI/DI 40195327045037 (case), 10195327045036 (unit), Lot Numbers: 22GLA027; j) REF

UPC codes

40889942325796, 10889942325795, 40888277877024, 10888277877023, 40889942279372, 10889942279371, 40889942925354, 10889942925353, 40195327044207, 10195327044206, 40889942805748, 10889942805747, 40195327045013, 10195327045012, 40195327314713, 10195327314712, 40195327045037, 10195327045036, 40195327044979, 10195327044978, 40195327511211, 10195327511210, 40195327446902, 10195327446901, 40195327510993, 10195327510992, 40193489244732, 10193489244731, 40889942750154, 10889942750153, 40888277745903, 10888277745902, 40195327505845, 10195327505844

Source

Official record: FDA (Device enforcement) ↗

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