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; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI PACK, REF DYKE1898; i) KIT, PEG, REG, REF DYKM2128; j) KIT,1500CC, 50CS, REF DYKM2126; k) LITHOTOMY, REF DYNJ909937; l) MAJOR BASIC, REF DYNJ909703; m) MINOR GENERAL SURGERY, REF DYNJ909940; n) SUCTION SET UP KIT, REF DYKM1187A; o) TURNOVER KIT, REF DYKC1274A; p) TURNOVER KIT MKT STRAPS, REF DYKC1309A; q) U BAR, REF DYNJ902374K
This recall is currently active, issued August 22, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- March 22, 2024
- Posted
- August 22, 2024
- Recall Number
- Z-2708-2024
- Quantity
- 75098 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
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 DYKM2126, UDI/DI 40195327044979 (case), 10195327044978 (unit), Lot Numbers: 22FBD067, 22FBW468, 22JBW467, 22KBS235, 23BBI456, 23DBO780, 23EBX215, 23HBP435, 23JBI233; k) REF DYNJ909937, UDI/DI 40195327511211 (case), 10195327511210 (unit), Lot Numbers: 23JBJ444, 23KBF560, 23LBE395; l) REF DYNJ909703, UDI/DI 40195327446902 (case), 10195327446901 (unit), Lot Numbers: 23HBQ115, 23JBG416, 23KBU600; m) REF DYNJ909940, UDI/DI 40195327510993 (case), 10195327510992 (unit), Lot Numbers: 23JBH986; n) REF DYKM1187A, UDI/DI 40193489244732 (case), 10193489244731 (unit), Lot Numbers: 22EMC363, 22FMD877, 22FMF873, 22HMF347, 22JMD898, 23AMA723, 23AMH732, 23BMI255, 23CME984, 23FMB442, 23GMC961, 23HMA663, 23JMB772; o) REF DYKC1274A, UDI/DI 40889942750154 (case), 10889942750153 (unit), Lot Numbers: 22FMA812, 22HMH967, 22LMD953, 23DMA533, 23EMH949, 23GMH687, 23JMJ195; p) REF DYKC1309A, UDI/DI 40888277745903 (case), 10888277745902 (unit), Lot Numbers: DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A, DYKC1309A; q) REF DYNJ902374K, UDI/DI 40195327505845 (case), 10195327505844 (unit), Lot Numbers: 23JBK113, 23KBO175, 23LBA437
Root Cause
Under Investigation by firm
Action Taken
Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.