FDAFDA · Alimentos y medicamentos·N.º oficial Z-3049-2024
Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100; 2) LAVH CDS, Pack Number CDS760049AD; 3) LAVH CDS, Pack Number CDS760049AF; 4) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056G ; 5) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088Q ; 6) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088R ; 7) ABDOMINAL HYSTERECTOMY CDS-LF , Pack Number CDS760088S ; 8) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186P ; 9) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186R ; 10) LAVH CDS, Pack Number CDS920130K ; 11) LAVH PROCEDURE, Pack Number CDS980754R ; 12) LAVH PROCEDURE, Pack Number CDS980754S ; 13) VAG HYST KIT, Pack Number CDS981313L ; 14) VAG HYST KIT, Pack Number CDS981313M ; 15) MINOR LITHOTOMY , Pack Number CDS982037W ; 16) MAJOR LITHOTOMY , Pack Number CDS982052V ; 17) D&C CDS , Pack Number CDS982061K ; 18) LAVH, Pack Number CDS982273Q ; 19) LAVH, Pack Number CDS982273R ; 20) LAVH, Pack Number CDS982273S ; 21) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397C ; 22) D&C HYSTEROSCOPY CDS-LF , Pack Number CDS982602K ; 23) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662P ; 24) GYN LAP HYSTERECTOMY CDS, Pack Number CDS982662Q ; 25) ABDOMINAL HYSTERECTOMY CDS SJF, Pack Number CDS982669N ; 26) GYN LITHOTOMY CDS SJF-LF, Pack Number CDS982679M ; 27) VAGINAL MAJOR , Pack Number CDS982689S ; 28) VAGINAL MAJOR , Pack Number CDS982689T ; 29) GYN/ABDOMINAL , Pack Number CDS982725K ; 30) GYN/ABDOMINAL , Pack Number CDS982725N ; 31) MAG MAJOR VAGINAL CDS , Pack Number CDS982907J ; 32) MAG MAJOR VAGINAL CDS , Pack Number CDS982907M ; 33) VAG HYST/SLING CDS-3, Pack Number CDS983006D ; 34) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055J ; 35) TOTAL LAPHYSTERECTOMY CDS , Pack Number CDS983055K ; 36) CUH LITHOTOMY CDS , Pack Number CDS983207M ; 37) CUH LITHOTOMY CDS , Pack Number CDS983207N ; 38) VAGINAL MINOR , Pack Number CDS983268I ; 39) LAVH CDS, Pack Number CDS983411I ; 40) LAVH CDS, Pack Number CDS983411J ; 41) LAVH CDS, Pack Number CDS983411K ; 42) LAVH PROCEDURE, Pack Number CDS983449L ; 43) LAVH PROCEDURE, Pack Number CDS983449M ; 44) LAVH PROCEDURE, Pack Number CDS983449N ; 45) LAVH CDS, Pack Number CDS983455C ; 46) MAJOR VAGINAL , Pack Number CDS983497J ; 47) MAJOR VAGINAL , Pack Number CDS983497L ; 48) LAPAROTOMY GYN CDS, Pack Number CDS983529M ; 49) VAG HYST CDS, Pack Number CDS983697J ; 50) GYN LITHOTOMY MAJOR LAC CDS , Pack Number CDS983780I ; 51) GYN MAJOR ABDOMINAL LAC CDS , Pack Number CDS983803K ; 52) GYN MINOR CDS , Pack Number CDS983985G ; 53) GYN ABDOMINAL CDS , Pack Number CDS983988A ; 54) MAJOR GYN LAPAROSCOPY CDS , Pack Number CDS984007C ; 55) TVT CDS , Pack Number CDS984091J ; 56) GROTH VAGINAL CDS , Pack Number CDS984201T ; 57) NHP Abdominal Hyst CDS, Pack Number CDS984234J ; 58) GYN CDS , Pack Number CDS984676C ; 59) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304; 60) TSH VAG HYSTERECTOMY CDS, Pack Number CDS985304A ; 61) DAVINCI HYSTERECTOMY CDS, Pack Number CDS985344F ; 62) HYSTEROSCOPY/D&C, Pack Number CDS985522G ; 63) MAJOR & MINOR LITHOTOMY , Pack Number CDS985525J ; 64) MAJOR LITHOTOMY , Pack Number CDS985547N ; 65) PROCEDURE TRAY, Pack Number DYNDA2966; 66) PERI-GYN PACK-LF, Pack Number DYNJ0038057A ; 67) TVH TRAY, Pack Number DYNJ00460L ; 68) TVH TRAY, Pack Number DYNJ00460M ; 69) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646F ; 70) D&C HYSTEROSCOPY PACK-LF, Pack Number DYNJ0046646G ; 71) LAVH PACK-LF, Pack Number DYNJ00470K ; 72) LAVH PACK-LF, Pack Number DYNJ00470L ; 73) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D ; 74) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768F ; 75) VAG. HYST TRAY-LF , Pack Number DYNJ0209066N ; 76) PERI GYN PACK-LF, Pack Number DYNJ0362432P ; 77) LAVH PACK-LF, Pack Number DYNJ0372824Q ; 78) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807I ; 79) VAGINAL HYSTERECTOMY PACK-LF, Pack Number DYNJ0373807J ; 80) VAGINAL HYSTERECTOMY PACK-
Publicado el 18 de septiembre de 2024 · Inicio del retiro: 8 de abril de 2024
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
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- MEDLINE INDUSTRIES, LP - Northfield
- Distribuidor
- Worldwide distribution.
- Lote
- C040100, Lot Number 19BDB794 ; C040100, Lot Number 19BDB938 ; C040100, Lot Number 19CDD009 ; C040100, Lot Number 19EDC262 ; C040100, Lot Number 19EDC533 ; C040100, Lot Number 19JDA569 ; C040100, Lot Number 19JDA836 ; C040100, Lot Number 19JDC293 ; C040100, Lot Number 19LDB582 ; C040100, Lot Number 20BDA227 ; C040100, Lot Number 20BDA828 ; C040100, Lot Number 20BDC639 ; C040100, Lot Number 20DDA503 ; C040100, Lot Number 20DDA627 ; C040100, Lot Number 20HDC033 ; C040100, Lot Number 21HDA277 ; C040100, Lot Number 22EDB968 ; C040100, Lot Number 22HDB951 ; CDS760049AD, Lot Number 21IBC904 ; CDS760049AD, Lot Number 21IBM329 ; CDS760049AD, Lot Number 21LBS989 ; CDS760049AD, Lot Number 22CBW119 ; CDS760049AD, Lot Number 22OBL416 ; CDS760049AD, Lot Number 22OBL970 ; CDS760049AD, Lot Number 22GBD274 ; CDS760049AD, Lot Number 22IBF092 ; CDS760049AD, Lot Number 22JBF094 ; CDS760049AD, Lot Number 22KBF472 ; CDS760049AD, Lot Number 22KBI850 ; CDS760049AD, Lot Number 23ABF834 ; CDS760049AD, Lot Number 23BBK772 ; CDS760049AD, Lot Number 23CBT560 ; CDS760049AD, Lot Number 23EBO959 ; CDS760049AD, Lot Number 23GBP399 ; CDS760049AD, Lot Number 23GBT911 ; CDS760049AD, Lot Number 23IBQ689 ; CDS760049AD, Lot Number 23JBI109 ; CDS760049AD, Lot Number 23KBD213 ; CDS760049AF, Lot Number 23LBV054 ; CDS760049AF, Lot Number 24ABR231 ; CDS760056G , Lot Number 22BBZ815 ; CDS760056G , Lot Number 22OBM631 ; CDS760056G , Lot Number 22JBI460 ; CDS760056G , Lot Number 23ABP479 ; CDS760056G , Lot Number 23FBG175 ; CDS760056G , Lot Number 23HBA191 ; CDS760056G , Lot Number 23IBP582 ; CDS760056G , Lot Number 23KBL445 ; CDS760056G , Lot Number 23KBP697 ; CDS760056G , Lot Number 24BBQ489 ; CDS760088Q , Lot Number 19CBG116 ; CDS760088Q , Lot Number 19DBG523 ; CDS760088R , Lot Number 21GBS618 ; CDS760088R , Lot Number 21HBB248 ; CDS760088R , Lot Number 21IBP890 ; CDS760088R , Lot Number 22OBM585 ; CDS760088R , Lot Number 19UBA526 ; CDS760088R , Lot Number 19JBX112 ; CDS760088R , Lot Number 19VBB261 ; CDS760088R , Lot Number 20BBZ171 ; CDS760088R , Lot Number 20GBU569 ; CDS760088R , Lot Number 20IBO653 ; CDS760088R , Lot Number 20KBS815 ; CDS760088R , Lot Number 20XBH134 ; CDS760088S , Lot Number 22HMG145 ; CDS760088S , Lot Number 22IMA901 ; CDS760088S , Lot Number 22JMG651 ; CDS830186P , Lot Number 22CBP266 ; CDS830186P , Lot Number 22DBK431 ; CDS830186P , Lot Number 22DBL618 ; CDS830186R , Lot Number 22FBR813 ; CDS830186R , Lot Number 22HBD852 ; CDS830186R , Lot Number 22IBA199 ; CDS920130K , Lot Number 23HME492 ; CDS920130K , Lot Number 23HME823 ; CDS920130K , Lot Number 23HMH121 ; CDS920130K , Lot Number 23IMF884 ; CDS980754R , Lot Number 23BMB975 ; CDS980754R , Lot Number 23BMC711 ; CDS980754S , Lot Number 23KMC281 ; CDS980754S , Lot Number 23KMG518 ; CDS980754S , Lot Number 23LMH962 ; CDS980754S , Lot Number 24AMG691 ; CDS980754S , Lot Number 24BMC635 ; CDS981313L , Lot Number 19ABX762 ; CDS981313L , Lot Number 19DBA731 ; CDS981313L , Lot Number 19EBY373 ; CDS981313L , Lot Number 19HBI633 ; CDS981313L , Lot Number 19JBT845 ; CDS981313L , Lot Number 20MBA368 ; CDS981313L , Lot Number 20CBR992 ; CDS981313L , Lot Number 20DBG990 ; CDS981313M , Lot Number 20IBD346 ; CDS981313M , Lot Number 20KBA286 ; CDS981313M , Lot Number 20KBU978 ; CDS981313M , Lot Number 20LBP521 ; CDS981313M , Lot Number 21CBA228 ; CDS981313M , Lot Number 21DBP142 ; CDS982037W , Lot Number 21LBF070 ; CDS982037W , Lot Number 22BBM902 ; CDS982037W , Lot Number 22BBR660 ; CDS982037W , Lot Number 22FBG184 ; CDS982037W , Lot Number 22FBR768 ; CDS982037W , Lot Number 22IBD070 ; CDS982037W , Lot Number 22KBS697 ; CDS982037W , Lot Number 23ABQ939 ; CDS982037W , Lot Number 23CBO799 ; CDS982037W , Lot Number 23EBN594 ; CDS982037W , Lot Number 23HBJ195 ; CDS982037W , Lot Number 23HBJ605 ; CDS982037W , Lot Number 23IBW115 ; CDS982037W , Lot Number 23JBV056 ; CDS982037W , Lot Number 23KMJ836 ; CDS9
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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