FDAFDA · Alimentos y medicamentos·N.º oficial Z-2983-2024
Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ; 3) AIRWAY EXAM KIT, Pack Number DYKE1796 ; 4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4; 5) INTUBATION KIT , Pack Number DYNDA1598C; 6) INTUBATION KIT , Pack Number DYNDA1598CH ; 7) ANESTHESIA KIT , Pack Number DYNDA2958; 8) ANESTHESIA PREP CUSTOM TRAY, Pack Number DYNDH1758; 9) ADULT LUMBAR PUNCTURE TRAY , Pack Number DYNDH1889; 10) PEDIATRIC CARDIAC PACK-LF, Pack Number DYNJ0537013Y; 11) PEDIATRIC MINOR PK, Pack Number DYNJ49035B; 12) WMC PEDIATRIC ADD ON PACK-LF, Pack Number DYNJ50644; 13) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283B; 14) ANESTHESIA CVL KIT-LF, Pack Number DYNJ52283C; 15) AIRWAY PACK , Pack Number DYNJ60239B; 16) ANESTHESIA PAIN PK LEAGUE, Pack Number DYNJ67925; 17) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603I ; 18) H-CABG INTRA OP ANESTHESIA , Pack Number DYNJ900603J ; 19) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503A ; 20) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503B ; 21) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503C ; 22) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503D ; 23) CV ANESTHESIA - ROOM SET UP, Pack Number DYNJ905503F ; 24) #######, Pack Number DYNJ905503F ; 25) MZ MDL AIRWAY, Pack Number DYNJ910129; 26) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA10379 ; 27) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA6572; 28) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE; 29) ANESTHESIA EVALUATION SAMPLE, Pack Number DYNJAASAMPLE; 30) REGIONAL ANESTHESIA PREP TRAY , Pack Number DYNJRA0376A ; 31) ANESTHESIA KIT , Pack Number DYNJRA0424A ; 32) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767; 33) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767A ; 34) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0767B ; 35) ANESTHESIA SUPPORT TRAY , Pack Number DYNJRA0779A ; 36) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA0887A ; 37) ANESTHESIA TRAY, Pack Number DYNJRA0909; 38) SPINAL ANESTHESIA TRAY/WHITE, Pack Number DYNJRA0955A ; 39) #####, Pack Number DYNJRA0955A ; 40) ANESTHESIA SUPPORT TRAY/B, Pack Number DYNJRA0968; 41) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119; 42) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA1119A ; 43) ANESTHESIA TRAY, Pack Number DYNJRA1355; 44) ANESTHESIA TRAY, Pack Number DYNJRA1355A ; 45) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1577A ; 46) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659; 47) ANESTHESIA SUPPORT TRAY/CHLORA, Pack Number DYNJRA1659A ; 48) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA1757; 49) ANESTHESIA PREP KIT, Pack Number DYNJRA1899; 50) ANESTHESIA TRAY, Pack Number DYNJRA1934; 51) ANESTHESIA SUPPORT TRAY-LF , Pack Number DYNJRA2087; 52) SPINAL ANESTHESIA TRAY, Pack Number DYNJRA2151; 53) PRE OP ANES KIT, Pack Number DYNJRA2228; 54) PRE OP ANES KIT, Pack Number DYNJRA2228H; 55) CUSTOM ANESTHESIA KIT-LF, Pack Number GSP478I; 56) REGIONAL TRAY, Pack Number PAIN0385B; 57) EPIDURAL ANESTHESIA KIT , Pack Number PAIN1982 ; 58) CIRC PACK-LF, Pack Number PHS41720I; 59) CIRC PACK-LF, Pack Number PHS41720J; 60) ANES CIRC 90 EXP, Pack Number VM96DLEX2L
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
- 35772, Lot Number 19GBK969 ; 81842, Lot Number 20JBS956 ; DYKE1796 , Lot Number 21GBR139 ; DYKE1796 , Lot Number 22HBX360 ; DYKE1796 , Lot Number 22JBR572 ; DYKSCRIPPSIN4, Lot Number 19DAA326 ; DYKSCRIPPSIN4, Lot Number 19EAA345 ; DYKSCRIPPSIN4, Lot Number 19HAB271 ; DYKSCRIPPSIN4, Lot Number 19LAA719 ; DYKSCRIPPSIN4, Lot Number 20AAA102 ; DYKSCRIPPSIN4, Lot Number 20BAA611 ; DYKSCRIPPSIN4, Lot Number 20DAA064 ; DYNDA1598C , Lot Number 23KMF159 ; DYNDA1598C , Lot Number 24AMG428 ; DYNDA1598CH, Lot Number 23KMF159 ; DYNDA1598CH, Lot Number 24AMG428 ; DYNDA2958, Lot Number 22KBH750 ; DYNDH1758, Lot Number 22HBX410 ; DYNDH1758, Lot Number 22JBU749 ; DYNDH1758, Lot Number 22LBK163 ; DYNDH1889, Lot Number 23HBZ539 ; DYNDH1889, Lot Number 23KBG134 ; DYNJ0537013Y , Lot Number 21LMD783 ; DYNJ49035B , Lot Number 19BDA167 ; DYNJ49035B , Lot Number 19CDC764 ; DYNJ49035B , Lot Number 19EDD455 ; DYNJ49035B , Lot Number 19GDC256 ; DYNJ49035B , Lot Number 19IDC024 ; DYNJ49035B , Lot Number 20ADA825 ; DYNJ49035B , Lot Number 20BDC864 ; DYNJ49035B , Lot Number 20DDA660 ; DYNJ49035B , Lot Number 20GDB084 ; DYNJ49035B , Lot Number 20IDB475 ; DYNJ49035B , Lot Number 20LDA638 ; DYNJ50644, Lot Number 21KBE704 ; DYNJ50644, Lot Number 22OBH075 ; DYNJ50644, Lot Number 22HBD748 ; DYNJ50644, Lot Number 19HBZ833 ; DYNJ50644, Lot Number 19JBI231 ; DYNJ50644, Lot Number 19VBB145 ; DYNJ50644, Lot Number 20BBB196 ; DYNJ50644, Lot Number 23JBW861 ; DYNJ52283B , Lot Number 19ABX422 ; DYNJ52283B , Lot Number 19BBT964 ; DYNJ52283C , Lot Number 21IBF288 ; DYNJ52283C , Lot Number 21JBX031 ; DYNJ52283C , Lot Number 21LBB738 ; DYNJ52283C , Lot Number 22ABA824 ; DYNJ52283C , Lot Number 22OBI904 ; DYNJ52283C , Lot Number 19DBO272 ; DYNJ52283C , Lot Number 19DBU670 ; DYNJ52283C , Lot Number 19FBM983 ; DYNJ52283C , Lot Number 22HBE294 ; DYNJ52283C , Lot Number 19GBL569 ; DYNJ52283C , Lot Number 19GBW600 ; DYNJ52283C , Lot Number 19SBC949 ; DYNJ52283C , Lot Number 22JBN210 ; DYNJ52283C , Lot Number 19JBT368 ; DYNJ52283C , Lot Number 19JBV109 ; DYNJ52283C , Lot Number 19VBH492 ; DYNJ52283C , Lot Number 19KBJ678 ; DYNJ52283C , Lot Number 19KBN283 ; DYNJ52283C , Lot Number 23BBU977 ; DYNJ52283C , Lot Number 19LBK922 ; DYNJ52283C , Lot Number 19LBS004 ; DYNJ52283C , Lot Number 20ABM461 ; DYNJ52283C , Lot Number 20ABP865 ; DYNJ52283C , Lot Number 23EBL084 ; DYNJ52283C , Lot Number 20BBJ414 ; DYNJ52283C , Lot Number 20BBS280 ; DYNJ52283C , Lot Number 23FBP678 ; DYNJ52283C , Lot Number 23HBK734 ; DYNJ52283C , Lot Number 20HBH238 ; DYNJ52283C , Lot Number 20JBJ550 ; DYNJ52283C , Lot Number 20JBN445 ; DYNJ52283C , Lot Number 20KBA832 ; DYNJ52283C , Lot Number 20KBP071 ; DYNJ52283C , Lot Number 21ABN133 ; DYNJ60239B , Lot Number 23LDA663 ; DYNJ67925, Lot Number 21GBR614 ; DYNJ67925, Lot Number 21JBL671 ; DYNJ67925, Lot Number 21LBO778 ; DYNJ67925, Lot Number 21LBO779 ; DYNJ67925, Lot Number 21LBO780 ; DYNJ67925, Lot Number 21LBO781 ; DYNJ67925, Lot Number 22ABA751 ; DYNJ67925, Lot Number 22ABQ043 ; DYNJ67925, Lot Number 22BBL497 ; DYNJ67925, Lot Number 22GBR405 ; DYNJ67925, Lot Number 22HBF644 ; DYNJ67925, Lot Number 22IBQ399 ; DYNJ67925, Lot Number 22KBU314 ; DYNJ67925, Lot Number 23ABO072 ; DYNJ67925, Lot Number 23ABT720 ; DYNJ67925, Lot Number 23CBF754 ; DYNJ67925, Lot Number 23DBP494 ; DYNJ67925, Lot Number 23FBJ744 ; DYNJ67925, Lot Number 23GBQ403 ; DYNJ67925, Lot Number 23HBE106 ; DYNJ67925, Lot Number 21ABA903 ; DYNJ67925, Lot Number 21ABW854 ; DYNJ67925, Lot Number 21DBP686 ; DYNJ67925, Lot Number 21EBH092 ; DYNJ900603I, Lot Number 20DDB314 ; DYNJ900603I, Lot Number 20FDB651 ; DYNJ900603I, Lot Number 20GDA926 ; DYNJ900603I, Lot Number 20HDA245 ; DYNJ900603I, Lot Number 20JDB313 ; DYNJ900603I, Lot Number 20JDB761 ; DYNJ900603I, Lot Number 20LDB998 ; DYNJ900603I, Lot Number 21ADB434 ; DYNJ900603I, Lot Number 21BDA664 ; DYNJ900603J, Lot Number 21HDC941 ; DYNJ900603
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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