FDA Medical devices recall · October 30, 2024

Medline brand medical procedure convenience kits… recall

Read the official FDA notice ↗

Product

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

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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), 100801968331

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0174-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.