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Medline medical procedure kits labeled as follows recallZ-2704-2024 · 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-2704-2024
Status
Open, Classified
Initiated by the company
Mar 22, 2024
Posted by the FDA
Aug 22, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
22891 units
Product code
FDE
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) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL LAPAROSCOPY V, REF DYNJS2032D; h) LAP APPY, REF DYNJ902383I; i) LAP CHOLE, REF DYNJ9062767D; j) LAP CHOLE, REF DYNJ907187A; k) MAJOR, REF DYNJ904768B; l) MAJOR, REF DYNJ905520F; m) MAJOR, REF DYNJ907154A; n) MAJOR SURGICAL, REF DYNJ905005C; o) MINOR, REF DYNJ907155A; p) MINOR SET UP, REF DYNJ909748; q) RHYZOTOMY, REF DYNJ902288I;

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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 DYNJ907187A, UDI/DI 40193489970525 (case), 10193489970524 (unit), Lot Numbers: 22EMH533, 22FME336, 22LMB229, 23AME424, 23AMJ064; k) REF DYNJ904768B, UDI/DI 40195327137183 (case), 10195327137182 (unit), Lot Numbers: 22EMG657, 22FMH099, 22IMA134, 22IMD626, 22JMF012, 23BMC481, 23BMG491, 23EMF946, 23GMB885, 23JMJ232, 23LMD177; l) REF DYNJ905520F, UDI/DI 40195327421367 (case), 10195327421366 (unit), Lot Numbers: 23HME815, 23HMH202, 23IMA899, 23JMC171, 23KMH256; m) REF DYNJ907154A, UDI/DI 40193489970341 (case), 10193489970340 (unit), Lot Numbers: 22FMH851, 22IMA525, 22LMF668, 23BMG402, 23DMD186, 23DME333, 23EMF068, 23HMD762, 23HMH492, 23KMC012; n) REF DYNJ905005C, UDI/DI 40195327316946 (case), 10195327316945 (unit), Lot Numbers: 23ABL864, 23CBF410, 23DBF768, 23GBS885, 23IBD450; o) REF DYNJ907155A, UDI/DI 40193489970273 (case), 10193489970272 (unit), Lot Numbers: 22KME231, 22LME429, 23AMF052, 23EMF507, 23JMA490; p) REF DYNJ909748, UDI/DI 40195327468218 (case), 10195327468217 (unit), Lot Numbers: 23IMI101, 23KMB382; q) REF DYNJ902288I, UDI/DI 40195327442225 (case), 10195327442224 (unit), Lot Numbers: 23GBD871, 23IBT374, 23KBD099;

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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