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Medline medical procedure kits labeled as follows recallZ-2708-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Mar 22, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-2708-2024
Status
Open, Classified
Initiated by the company
Mar 22, 2024
Posted by the FDA
Aug 22, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
75098 units
Product code
LRO
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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

Devices named in this recall

17 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94356).

Sources and updates

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