MEDLINE INDUSTRIES, LP - Northfield: Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DY

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: 22891 units Lot/code info: a) REF DYNJ905000D, UDI/DI 40195327316908 (case), 10195327316907 (unit), Lot Numbers: 23BBG363, 23CBN659, 23GBH840, 23HBE163, 23IBJ724, 23KBW116; b) REF DYKE1462A, UDI/DI 40889942620167 (case), 10889942620166 (unit), Lot Numbers: 22FDC042, 22JDB988, 22LBJ315, 23BBL256, 23CBU426, 23EBH275, 23FBK205, 23IBF933; c) REF DYKE1431B, UDI/DI 40889942632313 (case), 10889942632312 (unit), Lot Numbers: 22EME324, 22FMG304, 22HMH828, 22JMC383, 22LMC594, 23AMH794, 23BMF552, 23CME449, 23DMA460, 23FMF461, 23HMD372, 23JMB833, 23LMC072; d) REF DYKE1623B, UDI/DI 40193489424943 (case), 10193489424942 (unit), Lot Numbers: 22EBN239, 22FBQ906, 22JBS556, 23ABD205, 23DBD052, 23FBD026, 23HBQ564, 23KBQ077; e) REF DYNJ902385I, UDI/DI 40193489978279 (case), 10193489978278 (unit), Lot Numbers: 22IBL707, 23ABF810, 23ABS802, 23CBE830, 23CBM190, 23EBC428, 23FBU051, 23HBV225, 23KBR543; f) REF DYNJ905508G, UDI/DI 40195327269075 (case), 10195327269074 (unit), Lot Numbers: 22LME748, 22LMF477, 22LMI027, 23AMB893, 23AMG865, 23EMA933, 23EMB427, 23GMB051, 23HMI600, 23IMG463, 23KMB250; g) REF DYNJS2032D, UDI/DI 40193489214155 (case), 10193489214154 (unit), Lot Numbers: 22JDA825, 22LDB688, 23HDC128, 23KDA676; h) REF DYNJ902383I, UDI/DI 40193488978590 (case), 10193489978599 (unit), Lot Numbers: 22FBF410, 22FBM118, 22GBV826, 22KBJ795, 22LBB636, 23ABM564, 23DBI048, 23EBJ423, 23FBC990, 23HBS791, 23JBR485, 23KBQ988; i) REF DYNJ9062767D, UDI/DI 40195327511037 (case), 10195327511036 (unit), Lot Numbers: 23JBH731; j) REF DYNJ9

UPC codes

40195327316908, 10195327316907, 40889942620167, 10889942620166, 40889942632313, 10889942632312, 40193489424943, 10193489424942, 40193489978279, 10193489978278, 40195327269075, 10195327269074, 40193489214155, 10193489214154, 40193488978590, 10193489978599, 40195327511037, 10195327511036, 40193489970525, 10193489970524, 40195327137183, 10195327137182, 40195327421367, 10195327421366, 40193489970341, 10193489970340, 40195327316946, 10195327316945, 40193489970273, 10193489970272, 40195327468218, 10195327468217, 40195327442225, 10195327442224

Source

Official record: FDA (Device enforcement) ↗

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