CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
Medline medical procedure convenience kits, labeled as recalled
Medline Industries LP - Northfield is recalling Medline medical procedure convenience kits, labeled as: L&D/OB Pack-lf, distributed nationwide in the US. The recall was initiated on 4 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0174-2025
- FDA event ID
- 95415
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Sep 2024
- FDA classified
- 23 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 4 Sep 2024 | Recall initiated by company | |
| 23 Oct 2024 | Classified by FDA | +49 days |
| 30 Oct 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
32 other products · FDA event 95415This product is part of a recall event; the main page for the event is Medline medical procedure convenience kits, labeled as recalled.
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