FDAClass IIAugust 28, 2024

Medline medical procedure kits labeled as follows: a) recall

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…

Why was Medline medical procedure kits labeled as follows: a) recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
75098 units
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Recall date
August 28, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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