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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmMarch 22, 2024
Date PostedAugust 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2708-2024
Recall Event ID 94356
Product Classification General surgery tray - Product Code LRO
ProductMedline 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
Code Information 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
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
886-359-1704
Manufacturer Reason
for Recall		A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedline 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.
Quantity in Commerce75098 units
DistributionWorldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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