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Medline brand medical procedure convenience kits, labeled… recallZ-0174-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Sep 4, 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

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.

Recall details

Recall number
Z-0174-2025
Status
Open, Classified
Initiated by the company
Sep 4, 2024
Posted by the FDA
Oct 23, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
12,583 units
Product code
MLS
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Product description

Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, REF DYNJ0536939R; 6) LABOR & DELIVERY-LF, REF DYNJ07831F; 7) DELIVERY PACK-LF, REF DYNJ09982A; 8) DELIVERY PACK-LF, REF DYNJ09982A; 9) DELIVERY ROOM PACK, REF DYNJ14193C; 10) OB PACK, REF DYNJ17486I; 11) OB PACK, REF DYNJ17486I; 12) DELIVERY PACK, REF DYNJ24339K; 13) DELIVERY PACK, REF DYNJ26935A; 14) DELIVERY PACK, REF DYNJ26935A; 15) OB/DELIVERY ROOM PACK, REF DYNJ27262F; 16) VAGINAL DELIVERY TRAY, REF DYNJ27275; 17) VAGINAL DELIVERY, REF DYNJ28437F; 18) OB PACK, REF DYNJ31817K; 19) OB PACK, REF DYNJ31817K; 20) OB PACK, REF DYNJ36010F; 21) OB PACK, REF DYNJ38804G; 22) VAGINAL PACK, REF DYNJ40037A; 23) VAGINAL DELIVERY, REF DYNJ40170A; 24) VAG RECTAL PACK BWH-LF, REF DYNJ41694B; 25) OB DELIVERY PACK, REF DYNJ41994; 26) DELIVERY BUNDLE KIT, REF DYNJ43370A; 27) DELIVERY ROOM PACK, REF DYNJ44328G; 28) OB PACK, REF DYNJ44500F; 29) DELIVERY PACK, REF DYNJ47621A; 30) OB PACK, REF DYNJ50482G; 31) DELIVERY PACK, REF DYNJ52966C; 32) DELIVERY PACK, REF DYNJ57567; 33) LABOR & DELIVERY PACK, REF DYNJ57598; 34) OB DELIVERY PACK, REF DYNJ60784B; 35) VAGINAL DELIVERY PACK, REF DYNJ61662; 36) VAGINAL DELIVERY PACK, REF DYNJ61662; 37) LABOR AND DELIVERY PACK, REF DYNJ61864A; 38) PK, L&D-VAG DEL-MH, REF DYNJ62512A; 39) PK, L&D-VAG DEL-MH, REF DYNJ62512A; 40) VUWC OB PACK, REF DYNJ64017B; 41) OB PACK, REF DYNJ65525B; 42) VAG DELIVERY PACK, REF DYNJ66415; 43) VAGINAL DELIVERY PACK, REF DYNJ66970; 44) VAG DELIVERY, REF DYNJ67089; 45) VAGINAL DELIVERY PACK, REF DYNJ67111; 46) VAGINAL DELIVERY PACK, REF DYNJ67111; 47) AOMC MIDWIFE PACK, REF DYNJ67588; 48) VAGINAL DELIVERY TRAY, REF DYNJ68131A; 49) DELIVERY L&D PACK-CLEAR LAKE, REF DYNJ68247C; 50) DELIVERY L & D PACK, REF DYNJ68251D; 51) DELIVERY L & D PACK, REF DYNJ68251D; 52) SS VAGINAL DELIVERY PACK, REF DYNJ69512; 53) VAGINAL DELIVERY PACK, REF DYNJ69544A; 54) DELIVERY, REF DYNJ69721; 55) VAGINAL PACK, REF DYNJ69774A; 56) LABOR & DELIVERY PACK, REF DYNJ69833; 57) VAGINAL DELIVERY, REF DYNJ80532A; 58) OB PACK, REF DYNJ81878; 59) VAGINAL DELIVERY DISP PACK, REF DYNJ81917; 60) GENERAL DELIVERY PACK, REF DYNJ82447; 61) VAGINAL DELIVERY PACK, REF DYNJ82489B; 62) OB PACK, REF DYNJ82923; 63) OB PACK III, REF DYNJ82945; 64) OB PACK, REF DYNJ83196; 65) OB PACK, REF DYNJ83515; 66) 3027240 OB DELIVERY PACK, REF DYNJ84730; 67) DELIVERY PACK, REF DYNJ85860; 68) LABOR AND DELIVERY, REF DYNJ907794A; 69) LABOR AND DELIVERY, REF DYNJ907794A; 70) LABOR AND DELIVERY, REF DYNJ907794A; 71) VAGINAL DELIVERY, REF DYNJ908636A; 72) LABOR & DELIVERY PK I-LF, REF DYNJT0104G; 73) PACK VAGINAL DELIVERY, REF HM190A; 74) VAGINAL DELIVERY PACK-LF, REF PHS410140008D; 75) VAGINAL DELIVERY PACK, REF SYNJ10248B; 76) VAGINAL DELIVERY PACK, REF SYNJ10248B

Code information (models, lots, serial numbers)

Show the full code information (7k characters)

1) REF DYNJ0213264O, UDI/DI 40193489411912 (each), 10193489411911 (case), Lot Numbers: 23LBP214; 2) REF DYNJ0375486K, UDI/DI 40889942232865 (each), 10889942232864 (case), Lot Numbers: 23LBQ906; 3) REF DYNJ0375486K, UDI/DI 40889942232865 (each), 10889942232864 (case), Lot Numbers: 23KBO506; 4) REF DYNJ04865M, UDI/DI 40195327188123 (each), 10195327188122 (case), Lot Numbers: 23LBP871; 5) REF DYNJ0536939R, UDI/DI 40195327206223 (each), 10195327206222 (case), Lot Numbers: 24ABC134; 6) REF DYNJ07831F, UDI/DI 40888277841131 (each), 10888277841130 (case), Lot Numbers: 24ABK556; 7) REF DYNJ09982A, UDI/DI 40888277860521 (each), 10888277860520 (case), Lot Numbers: 24ABE463; 8) REF DYNJ09982A, UDI/DI 40888277860521 (each), 10888277860520 (case), Lot Numbers: 23KBF261; 9) REF DYNJ14193C, UDI/DI 40195327410002 (each), 10195327410001 (case), Lot Numbers: 24ABA112; 10) REF DYNJ17486I, UDI/DI 40195327224388 (each), 10195327224387 (case), Lot Numbers: 23LBM930; 11) REF DYNJ17486I, UDI/DI 40195327224388 (each), 10195327224387 (case), Lot Numbers: 23KBF343; 12) REF DYNJ24339K, UDI/DI 40195327597352 (each), 10195327597351 (case), Lot Numbers: 24ABB322; 13) REF DYNJ26935A, UDI/DI 40080196655138 (each), 10080196655137 (case), Lot Numbers: 24ABF439; 14) REF DYNJ26935A, UDI/DI 40080196655138 (each), 10080196655137 (case), Lot Numbers: 23KBF264; 15) REF DYNJ27262F, UDI/DI 40195327302925 (each), 10195327302924 (case), Lot Numbers: 23LBR393; 16) REF DYNJ27275, UDI/DI 40080196833116 (each), 10080196833115 (case), Lot Numbers: 24ABF229; 17) REF DYNJ28437F, UDI/DI 40193489800518 (each), 10193489800517 (case), Lot Numbers: 23LBP215; 18) REF DYNJ31817K, UDI/DI 40195327502172 (each), 10195327502171 (case), Lot Numbers: 24ABE494; 19) REF DYNJ31817K, UDI/DI 40195327502172 (each), 10195327502171 (case), Lot Numbers: 24ABE736; 20) REF DYNJ36010F, UDI/DI 40195327409907 (each), 10195327409906 (case), Lot Numbers: 23KBO470; 21) REF DYNJ38804G, UDI/DI 40195327113101 (each), 10195327113100 (case), Lot Numbers: 24ABF285; 22) REF DYNJ40037A, UDI/DI 40889942253792 (each), 10889942253791 (case), Lot Numbers: 23KBD900; 23) REF DYNJ40170A, UDI/DI 40195327007981 (each), 10195327007980 (case), Lot Numbers: 24ABH933; 24) REF DYNJ41694B, UDI/DI 40193489662819 (each), 10193489662818 (case), Lot Numbers: 23KBI386; 25) REF DYNJ41994, UDI/DI 40884389912509 (each), 10884389912508 (case), Lot Numbers: 23KBM567; 26) REF DYNJ43370A, UDI/DI 40888277854124 (each), 10888277854123 (case), Lot Numbers: 24ABE458; 27) REF DYNJ44328G, UDI/DI 40195327165940 (each), 10195327165949 (case), Lot Numbers: 24ABA443; 28) REF DYNJ44500F, UDI/DI 40193489905497 (each), 10193489905496 (case), Lot Numbers: 24ABG242; 29) REF DYNJ47621A, UDI/DI 40193489203418 (each), 10193489203417 (case), Lot Numbers: 23LBM902; 30) REF DYNJ50482G, UDI/DI 40195327190188 (each), 10195327190187 (case), Lot Numbers: 24ABE007; 31) REF DYNJ52966C, UDI/DI 40193489237154 (each), 10193489237153 (case), Lot Numbers: 23LBP186; 32) REF DYNJ57567, UDI/DI 40889942753209 (each), 10889942753208 (case), Lot Numbers: 23LBP083; 33) REF DYNJ57598, UDI/DI 40889942756248 (each), 10889942756247 (case), Lot Numbers: 24ABN293; 34) REF DYNJ60784B, UDI/DI 40195327456444 (each), 10195327456443 (case), Lot Numbers: 23KBD079; 35) REF DYNJ61662, UDI/DI 40193489587303 (each), 10193489587302 (case), Lot Numbers: 24ABA680; 36) REF DYNJ61662, UDI/DI 40193489587303 (each), 10193489587302 (case), Lot Numbers: 23LBP067; 37) REF DYNJ61864A, UDI/DI 40195327213481 (each), 10195327213480 (case), Lot Numbers: 23LBM885; 38) REF DYNJ62512A, UDI/DI 40193489410007 (each), 10193489410006 (case), Lot Numbers: 23LBN089; 39) REF DYNJ62512A, UDI/DI 40193489410007 (each), 10193489410006 (case), Lot Numbers: 23KBC461; 40) REF DYNJ64017B, UDI/DI 40195327550326 (each), 10195327550325 (case), Lot Numbers: 24ABC789; 41) REF DYNJ65525B, UDI/DI 40195327403332 (each), 10195327403331 (case), Lot Numbers: 23LBP080; 42) REF DYNJ66415, UDI/DI 40193489353182 (each), 10193489353181 (case), Lot Numbers: 23KBE863; 43) REF DYNJ66970, UDI/DI 40193489384636 (each), 10193489384635 (case), Lot Numbers: 24ABA626; 44) REF DYNJ67089, UDI/DI 40193489385497 (each), 10193489385496 (case), Lot Numbers: 23KBF696; 45) REF DYNJ67111, UDI/DI 40193489387354 (each), 10193489387353 (case), Lot Numbers: 24ABB663; 46) REF DYNJ67111, UDI/DI 40193489387354 (each), 10193489387353 (case), Lot Numbers: 23KBB422; 47) REF DYNJ67588, UDI/DI 40193489416931 (each), 10193489416930 (case), Lot Numbers: 24ABE006; 48) REF DYNJ68131A, UDI/DI 40195327453849 (each), 10195327453848 (case), Lot Numbers: 23LBS187; 49) REF DYNJ68247C, UDI/DI 40195327507665 (each), 10195327507664 (case), Lot Numbers: 23KBF880; 50) REF DYNJ68251D, UDI/DI 40195327506460 (each), 10195327506469 (case), Lot Numbers: 23LBM746; 51) REF DYNJ68251D, UDI/DI 40195327506460 (each), 10195327506469 (case), Lot Numbers: 23KBE824; 52) REF DYNJ69512, UDI/DI 40193489949248 (each), 10193489949247 (case), Lot Numbers: 23LBP605; 53) REF DYNJ69544A, UDI/DI 40195327325368 (each), 10195327325367 (case), Lot Numbers: 23LBU620; 54) REF DYNJ69721, UDI/DI 40193489973076 (each), 10193489973075 (case), Lot Numbers: 24ABA088; 55) REF DYNJ69774A, UDI/DI 40195327328369 (each), 10195327328368 (case), Lot Numbers: 23KBM418; 56) REF DYNJ69833, UDI/DI 40193489983419 (each), 10193489983418 (case), Lot Numbers: 23LBP238; 57) REF DYNJ80532A, UDI/DI 40195327064649 (each), 10195327064648 (case), Lot Numbers: 23KBD408; 58) REF DYNJ81878, UDI/DI 40195327153572 (each), 10195327153571 (case), Lot Numbers: 23LBR963; 59) REF DYNJ81917, UDI/DI 40195327155347 (each), 10195327155346 (case), Lot Numbers: 24ABG346; 60) REF DYNJ82447, UDI/DI 40195327196951 (each), 10195327196950 (case), Lot Numbers: 23KBF548; 61) REF DYNJ82489B, UDI/DI 40195327361298 (each), 10195327361297 (case), Lot Numbers: 23LBJ943; 62) REF DYNJ82923, UDI/DI 40195327219421 (each), 10195327219420 (case), Lot Numbers: 24ABG248; 63) REF DYNJ82945, UDI/DI 40195327218868 (each), 10195327218867 (case), Lot Numbers: 23LBP176; 64) REF DYNJ83196, UDI/DI 40195327243976 (each), 10195327243975 (case), Lot Numbers: 24ABE294; 65) REF DYNJ83515, UDI/DI 40195327275045 (each), 10195327275044 (case), Lot Numbers: 24ABD211; 66) REF DYNJ84730, UDI/DI 40195327407712 (each), 10195327407711 (case), Lot Numbers: 23LBN461; 67) REF DYNJ85860, UDI/DI 40195327560233 (each), 10195327560232 (case), Lot Numbers: 23LBP250; 68) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 24EBF501; 69) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 24BBS293; 70) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 23KBT943; 71) REF DYNJ908636A, UDI/DI 40195327314980 (each), 10195327314989 (case), Lot Numbers: 23LBE142; 72) REF DYNJT0104G, UDI/DI 40889942741442 (each), 10889942741441 (case), Lot Numbers: 23LBL842; 73) REF HM190A, UDI/DI 40195327305162 (each), 10195327305161 (case), Lot Numbers: 23LBP164; 74) REF PHS410140008D, UDI/DI 40195327503131 (each), 10195327503130 (case), Lot Numbers: 23KBS958; 75) REF SYNJ10248B, UDI/DI 40193489373388 (each), 10193489373387 (case), Lot Numbers: 24ABA624; 76) REF SYNJ10248B, UDI/DI 40193489373388 (each), 10193489373387 (case), Lot Numbers: 23KBE181

Devices named in this recall

65 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 95415).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page