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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2108-2026

Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38B; 6) L & D PACK-LF, Model Number: DYNJ0456816O; 7) L & D PACK-LF, Model Number: DYNJ0456816P; 8) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 10) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 11) DELIVERY PACK-LF, Model Number: DYNJ20546F; 12) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 13) VAGINAL DELIVERY PK, Model Number: DYNJ20979J; 14) VAGINAL DELIVERY PACK, Model Number: DYNJ24108D; 15) OB PACK-LF, Model Number: DYNJ26121I; 16) OB DELIVERY PACK, Model Number: DYNJ31024J; 17) OB DELIVERY PACK-LF, Model Number: DYNJ32139C; 18) DB VAG HYSTERECTOMY-LF, Model Number: DYNJ33590F; 19) MAJOR VAGINAL PACK, Model Number: DYNJ35488F; 20) ENS. ACCOUCHEMENT VAGINAL-LF, Model Number: DYNJ37331C; 21) VAG DELIVERY PACK, Model Number: DYNJ38481G; 22) VAG DELIVERY PACK, Model Number: DYNJ38481I; 23) VAG DELIVERY PACK, Model Number: DYNJ38481K; 24) OB PACK 2, Model Number: DYNJ39000D; 25) GYNECOLOGY VAGINAL KIT, Model Number: DYNJ40203A; 26) LABOR DELIVERY POUCH SCREEN, Model Number: DYNJ40918A; 27) L & D PACK WITHOUT INSTRUMENTS, Model Number: DYNJ44720B; 28) VAGINAL DELIVERY PACK, Model Number: DYNJ51377G; 29) FH VAG DELIVERY PK-LF, Model Number: DYNJ51794B; 30) VAGINAL DELIVERY PACK, Model Number: DYNJ55363A; 31) VAGINAL DELIVERY PACK, Model Number: DYNJ55363B; 32) DELIVERY PACK, Model Number: DYNJ55373A; 33) VAGINAL DELIVERY PACK, Model Number: DYNJ59403F; 34) MINOR VAGINAL PACK, Model Number: DYNJ61269B; 35) OB VAG DELIVERY PACK, Model Number: DYNJ61574; 36) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ61650; 37) OB-VAG PACK 9128190, Model Number: DYNJ62341; 38) HP VAGINAL DELIVERY PACK-LF, Model Number: DYNJ62402A; 39) LABOR AND DELIVERY TRAY, Model Number: DYNJ62722B; 40) L & D PACK, Model Number: DYNJ63216A; 41) L&D PACK, Model Number: DYNJ63757A; 42) GYN PACK DYNJ55833A, Model Number: DYNJ65145; 43) MINOR VAG PACK, Model Number: DYNJ68663; 44) UTHET TYLER OB PACK, Model Number: DYNJ68673A; 45) GYN VAGINAL PACK, Model Number: DYNJ68681; 46) VAGINAL DELIVERY PACK, Model Number: DYNJ69544A; 47) VAGINAL PACK, Model Number: DYNJ69774A; 48) LABOR & DELIVERY PACK-LF, Model Number: DYNJ84393; 49) DELIVERY PACK, Model Number: DYNJ87469A; 50) DELIVERY B, Model Number: DYNJ900351T; 51) VAGINAL DELIVERY, Model Number: DYNJ901387A; 52) FLOYD DELIVERY, Model Number: DYNJ906937D; 53) OB VAGINAL MEDSTAR PACK-LF, Model Number: DYNJT3445; 54) OB PACK, Model Number: DYNJT5186; 55) VAGINAL DELIVERY KIT, Model Number: MNS13550A; 56) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 57) LABOR AND DELIVERY KIT, Model Number: MNS8950A

Publicado el 13 de mayo de 2026 · Inicio del retiro: 7 de enero de 2026

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medline Industries, LP
Distribuidor
Worldwide - US Nationwide distribution.
Lote
1) DYKM2326, UDI-DI: 10198459565748(each), 40198459565749(case), Lot Number: 25KMF765; 2) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABI982; 3) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABT654; 4) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21DBA335; 5) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21EBE875; 6) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21FBP760; 7) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21GBN267; 8) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBE978; 9) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBO498; 10) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21JBQ910; 11) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21KBM483; 12) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21LBX453; 13) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22IBB499; 14) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22KBS631; 15) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22LBB693; 16) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23BBT994; 17) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23EBP170; 18) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23HBR548; 19) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBA329; 20) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBV905; 21) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 24ABK386; 22) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 21ABC201; 23) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 23JLA066; 24) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 23JLA538; 25) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 21ABM087; 26) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 23IBT256; 27) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 23JBB705; 28) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24IBK537; 29) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24IBM370; 30) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24IBW265; 31) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24JBK520; 32) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JMC541; 33) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JME434; 34) DYNJ0456816P, UDI-DI: 10195327570545(each), 40195327570546(case), Lot Number: 24HMK119; 35) DYNJ04692S, UDI-DI: 10193489338454(each), 40193489338455(case), Lot Number: 21ADB239; 36) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 23KMJ818; 37) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24BMA554; 38) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24CMB999; 39) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24DMI443; 40) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24FMF250; 41) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24GMJ484; 42) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24IMF157; 43) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24JMB353; 44) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25AME014; 45) DYNJ16621B, UDI-D
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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