Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAG

Summary

The FDA issued a Class II for Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PAC by MEDLINE INDUSTRIES, LP - Northfield. Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits..

Details

Product Description

Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5) PACK VAGINAL DELIVERY, Model Number: HM190A; 6) VAGINAL DELIVERY PACK, Model Number: SYNJ10248B; 7) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209; 8) VAG DELIVERY PACK-6220, Model Number: DYNJ49542B; 9) FHT VAG DELIVERY PACK, Model Number: DYNJ37124C; 10) VAGINAL DEL PK, Model Number: DYNJ65689; 11) PK,L&D-VAG DEL, Model Number: DYNJ43737D; 12) L&D PACK-LF, Model Number: DYNJ0731657M; 13) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ43604B; 14) VAD ACCESS, Model Number: DYNJ24276C; 15) VAGINAL DELIVERY PACK, Model Number: DYNJ80304; 16) VAGINAL DELIVERY CDS, Model Number: CDS982762I; 17) VAGINAL DELIVERY, Model Number: DYNJ903796C; 18) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D; 19) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D; 20) BR L&D PACK, Model Number: DYNJ47625B; 21) OB PACK, Model Number: DYNJ03387B; 22) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 23) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 24) VAGINAL DELIVERY PACK, Model Number: DYNJ23158B; 25) L AND D PACK, Model Number: DYNJHTLD03A; 26) PK,L&D-VAG DEL, Model Number: DYNJ43737D; 27) VAG DELIVERY PACK, Model Number: DYNJ34949; 28) OB PACK, Model Number: DYNJ55835B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A; 30) OB PACK, Model Number: DYNJ83115; 31) VAGINAL DEL PK, Model Number: DYNJ65689; 32) LDRP-OBSTETRICAL PACK-LF, Model Number: DYNJ64828B; 33) LABOR & DELIVERY PACK, Model Number: DYNJ69433; 34) LABOR & DELIVERY II-LF, Model Number: DYNJS8250; 35) VAGINAL DELIVERY PACK-MARY IMM, Model Number: DYNJ24514G; 36) CUSTOM VAGINAL DELIVERY, Model Number: DYNJ63270C; 37) BHS STANDARD VAGINAL DELIVERY, Model Number: DYNJ80329; 38) OB VAGINAL PACK-LF, Model Number: DYNJ40009D; 39) DELIVERY PACK ME-LF RF, Model Number: DYNJ45589F; 40) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ82620A; 41) VAGINAL DELIVERY, Model Number: DYNJ903796C; 42) DELIVERY PACK, Model Number: DYNJ69964; 43) VAGINAL DELIVERY PACK, Model Number: DYNJ34315D; 44) VAGINAL DELIVERY PACK, Model Number: DYNJ57668A; 45) VAG DELIVERY PACK CHS-LF, Model Number: DYNJ35608K; 46) O.B. PACK-LF, Model Number: DYNJ07520J; 47) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209; 48) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A; 49) CUH VAGINAL-LF, Model Number: DYNJC9242C; 50) VAGINAL DELIVERY, Model Number: DYNJ903796C; 51) VAGINAL DELIVERY, Model Number: DYNJ907958; 52) VAG DEL PROCEDURE MCSETX, Model Number: DYNJ908581A; 53) CUH VAGINAL-LF, Model Number: DYNJC9242C; 54) VAGINAL DELIVERY, Model Number: DYNJ903796C; 55) VAGINAL DELIVERY, Model Number: DYNJ907958

Lot/Code Info: 1) DYNJ26971L, UDI-DI: 10198459087158(each), 40198459087159(case), Lot Number: 24IBD872; 2) DYNJ0378319P, UDI-DI: 10198459105722(each), 40198459105723(case), Lot Number: 24IBF374; 3) DYNJ64017B, UDI-DI: 10195327550325(each), 40195327550326(case), Lot Number: 24IBG070; 4) DYNJHTLD04A, UDI-DI: 10193489303346(each), 40193489303347(case), Lot Number: 24IBH288; 5) HM190A, UDI-DI: 10195327305161(each), 40195327305162(case), Lot Number: 24IBH818; 6) SYNJ10248B, UDI-DI: 10193489373387(each), 40193489373388(case), Lot Number: 24IBH820; 7) DYNJ84209, UDI-DI: 10195327342739(each), 40195327342730(case), Lot Number: 24IBH988; 8) DYNJ49542B, UDI-DI: 10195327388072(each), 40195327388073(case), Lot Number: 24IBR452; 9) DYNJ37124C, UDI-DI: 10195327416195(each), 40195327416196(case), Lot Number: 24IBR491; 10) DYNJ65689, UDI-DI: 10193489284836(each), 40193489284837(case), Lot Number: 24IBR570; 11) DYNJ43737D, UDI-DI: 10193489350845(each), 40193489350846(case), Lot Number: 24IBR650; 12) DYNJ0731657M, UDI-DI: 10195327697020(each), 40195327697021(case), Lot Number: 24IBR661; 13) DYNJ43604B, UDI-DI: 10193489997521(each), 40193489997522(case), Lot Number: 24IBR707; 14) DYNJ24276C, UDI-DI: 10884389431184(each), 40884389431185(case), Lot Number: 24IBS408; 15) DYNJ80304, UDI-DI: 10195327022532(each), 40195327022533(case), Lot Number: 24IBS686; 16) CDS982762I, UDI-DI: 10193489942095(each), 40193489942096(case), Lot Number: 24JBB609; 17) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24JBE762; 18) DYNJ43677D, UDI-DI: 10193489768589(each), 40193489768580(case), Lot Number: 24JBM324; 19) DYNJ43677D, UDI-DI: 10193489768589(each), 40193489768580(case), Lot Number: 24JBM600; 20) DYNJ47625B, UDI-DI: 10889942182589(each), 40889942182580(case), Lot Number: 24JBN320; 21) DYNJ03387B, UDI-DI: 10195327191092(each), 40195327191093(case), Lot Number: 24JBO026; 22) DYNJHTLD04A, UDI-DI: 10193489303346(each), 40193489303347(case), Lot Number: 24JBR630; 23) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24JBU227; 24) DYNJ23158B, UDI-DI: 10195327473891(each), 40195327473892(case), Lot Number: 24JBU459; 25) DYNJHTLD03A, UDI-DI: 10193489303353(each), 40193489303354(case), Lot Number: 24JBU555; 26) DYNJ43737D, UDI-DI: 10193489350845(each), 40193489350846(case), Lot Number: 24JBV052; 27) DYNJ34949, UDI-DI: 10884389403358(each), 40884389403359(case), Lot Number: 24JBV802; 28) DYNJ55835B, UDI-DI: 10195327319946(each), 40195327319947(case), Lot Number: 24JBV820; 29) DYNJ68778A, UDI-DI: 10198459035852(each), 40198459035853(case), Lot Number: 24JBV866; 30) DYNJ83115, UDI-DI: 10195327232979(each), 40195327232970(case), Lot Number: 24JBV884; 31) DYNJ65689, UDI-DI: 10193489284836(each), 40193489284837(case), Lot Number: 24JBW792; 32) DYNJ64828B, UDI-DI: 10198459140280(each), 40198459140281(case), Lot Number: 24JBX788; 33) DYNJ69433, UDI-DI: 10193489940985(each), 40193489940986(case), Lot Number: 24JBX797; 34) DYNJS8250, UDI-DI: 10884389349298(each), 40884389349299(case), Lot Number: 24KBA046; 35) DYNJ24514G, UDI-DI: 10193489893656(each), 40193489893657(case), Lot Number: 24KBA388; 36) DYNJ63270C, UDI-DI: 10193489862614(each), 40193489862615(case), Lot Number: 24KBB101; 37) DYNJ80329, UDI-DI: 10195327027193(each), 40195327027194(case), Lot Number: 24KBB586; 38) DYNJ40009D, UDI-DI: 10195327362362(each), 40195327362363(case), Lot Number: 24KBC597; 39) DYNJ45589F, UDI-DI: 10198459125904(each), 40198459125905(case), Lot Number: 24KBC628; 40) DYNJ82620A, UDI-DI: 10198459150081(each), 40198459150082(case), Lot Number: 24KBC810; 41) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24KBD009; 42) DYNJ69964, UDI-DI: 10195327000660(each), 40195327000661(case), Lot Number: 24KBE397; 43) DYNJ34315D, UDI-DI: 10198459168369(each), 40198459168360(case), Lot Number: 24KBF136; 44) DYNJ57668A, UDI-DI: 10193489795622(each), 40193489795623(case), Lot Number: 24KBG150; 45) DYNJ35608K, UDI-DI: 10195327099022(each), 40195327099023(case), Lot Number: 24KBG823; 46) DYNJ07520J, UDI-DI: 10198459015533(each), 40198459015534(case), Lot Number: 24KBG847; 47) DYNJ84209, UDI-DI: 10195327342739(each), 40195327342730(case), Lot Number: 24KBG879; 48) DYNJ68778A, UDI-DI: 10198459035852(each), 40198459035853(case), Lot Number: 24KBH870; 49) DYNJC9242C, UDI-DI: 10193489568882(each), 40193489568883(case), Lot Number: 24KBL933; 50) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24KBN086; 51) DYNJ907958, UDI-DI: 10193489949445(each), 40193489949446(case), Lot Number: 24KBQ773; 52) DYNJ908581A, UDI-DI: 10195327594664(each), 40195327594665(case), Lot Number: 24KBU702; 53) DYNJC9242C, UDI-DI: 10193489568882(each), 40193489568883(case), Lot Number: 24LBK538; 54) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24LBO942; 55) DYNJ907958, UDI-DI: 10193489949445(each), 40193489949446(case), Lot Number: 25ABA840

Quantity Affected: 21935 units

Reason for Recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-03-03

Company