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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3019-2024

Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; 3) BIOPSY PROCEDURE PACK, Pack Number 00-399607N; 4) THORACENTESIS TRAY, Pack Number 00-400616J ; 5) SPECIAL PROCEDURE PACKX-RAY , Pack Number 00-400830S ; 6) PROCEDURE PACK-LF , Pack Number 00-401585M ; 7) PTCA PACK , Pack Number 00-401800F ; 8) ANGIO PROCEDURE PACK, Pack Number 00-401824Y ; 9) PICC LINE TRAY, Pack Number 00-401993N ; 10) ARTERIOGRAM TRAY, Pack Number 00-402001S ; 11) CARDIAC CATH PACK , Pack Number 00-500502L ; 12) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377N; 13) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377O; 14) BAPTIST MEMORIAL PACK , Pack Number 0M-CP31377P; 15) KIT IR CUSTOM-ST CLOUD, Pack Number 131672; 16) KIT ANGIO CSTM, Pack Number 135169; 17) KIT NEURO 2-UIC, Pack Number 138557; 18) STOP THE BURDEN KIT IN PACK , Pack Number 139594 ; 19) KIT ANGIO CSTM-ST FRANCIS, Pack Number 142356; 20) TISSUE PROCUREMENT KIT1506US1 , Pack Number 1506US1; 21) BASIC TRIAL ACCESSORIES , Pack Number 190-0033-002 ; 22) PROC AC KIT LIDOCAINE , Pack Number 20060920 ; 23) PROCEDURAL ACC KIT, Pack Number 20060921 ; 24) DA VINCI ACCESSORIES KIT: GYN , Pack Number 387000 ; 25) DA VINCI ACCESSORIES KIT: UROL, Pack Number 387100 ; 26) DA VINCI ACCESSORIES KIT: GS, Pack Number 387200 ; 27) BASIC PROCEDURE PACK, Pack Number 7790 ; 28) COMP PROC PACK W/CHLORAPREP , Pack Number 7792 ; 29) PHLEBECTOMY PROCEDURE PACK, Pack Number 7793 ; 30) PROCEDURE PACK, RF, Pack Number 7795 ; 31) PROCEDURE PACK, RF, BASIC , Pack Number 7798 ; 32) SKIN RECOVERY PACK M1S0706-LF , Pack Number 922095 ; 33) CVHP DRAWER-SYR & TUBING VER.A, Pack Number ACC010309A ; 34) NEWBORN RESUSCITATION KIT , Pack Number ACC010381C ; 35) NEONATAL DRAWER 6 , Pack Number ACC010653; 36) ANGEL PERCUTANEOUS ACCESS KIT , Pack Number AK9035A; 37) RADIAL TRAY , Pack Number AM140A ; 38) RADIAL TRAY , Pack Number AM140B ; 39) SET UP TRAY , Pack Number AM235A ; 40) PACK SET UP , Pack Number AM235B ; 41) HEAD & NECK TRAY, Pack Number AM310A ; 42) 18GX6 FEMORAL ART MAX BARRIER KIT, Pack Number ART1230; 43) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 44) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 45) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 46) BIOBURDEN TEST KIT - 110, Pack Number BIOB110; 47) BIOBURDEN TEST KIT - 686, Pack Number BIOB686; 48) BIOBURDEN TEST KIT - 710, Pack Number BIOB710; 49) BM ECTOPIC SINUS SURGERY, Pack Number BM100A ; 50) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056D ; 51) MAJOR LITHOTOMY CDS-LF, Pack Number CDS760056F ; 52) CYSTO PROCEDURE , Pack Number CDS760062O ; 53) NEURO CDS , Pack Number CDS780056M ; 54) SHUNT CDS-LF, Pack Number CDS780103J ; 55) TRAUMA/LIVER CDS-LF , Pack Number CDS780104J ; 56) TRAUMA/LIVER CDS-LF , Pack Number CDS780104K ; 57) UVALDE C-SECTION CDS, Pack Number CDS820116D ; 58) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136R ; 59) VASCULAR EXTREMITY CDS-LF , Pack Number CDS840055O ; 60) AAA CDS , Pack Number CDS840076AB; 61) AAA CDS , Pack Number CDS840076X ; 62) AAA CDS , Pack Number CDS840076Y ; 63) OFF PUMP CABG CDS , Pack Number CDS840087AA; 64) OFF PUMP CABG CDS , Pack Number CDS840087AC; 65) OPEN HEART, Pack Number CDS840150Q ; 66) VALVE PACK, Pack Number CDS840187R ; 67) AV FISTULA PACK , Pack Number CDS840188L ; 68) MAJOR VASCULAR PACK , Pack Number CDS840195S ; 69) FETAL SURGERY CDS-LF, Pack Number CDS840214N ; 70) FETOSCOPY CDS-LF, Pack Number CDS840215N ; 71) MAJOR VASCULAR-LF , Pack Number CDS840232J ; 72) AVF-LF, Pack Number CDS840233D ; 73) AVF-LF, Pack Number CDS840233F ; 74) AVF-LF, Pack Number CDS840233G ; 75) GENERAL AAA #11-RF, Pack Number CDS840261AA; 76) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295F ; 77) PERIPHERAL INSERTION CDS-LF , Pack Number CDS840343K ; 78) THOROCOTOMY , Pack Number CDS840354N ; 79) THOROCOTOMY , Pack Number CDS840354O ; 80) THORO

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
00-399025L , Lot Number 23LMB058 ; 00-399025L , Lot Number 23LMG684 ; 00-399025L , Lot Number 23LMH827 ; 00-399025L , Lot Number 24AMC410 ; 00-399025L , Lot Number 19ELA658 ; 00-399025L , Lot Number 19KLA410 ; 00-399025L , Lot Number 20BLA276 ; 00-399025L , Lot Number 20CLA517 ; 00-399025L , Lot Number 20GLA372 ; 00-399025L , Lot Number 20JLA514 ; 00-399025L , Lot Number 21ELA301 ; 00-399025L , Lot Number 21HLA415 ; 00-399025L , Lot Number 21JLA793 ; 00-399025L , Lot Number 22CLA145 ; 00-399025L , Lot Number 22ELA199 ; 00-399025L , Lot Number 22ELA628 ; 00-399025L , Lot Number 22JLA233 ; 00-399025L , Lot Number 23ALA823 ; 00-399025L , Lot Number 23ELA753 ; 00-399025L , Lot Number 23ELB229 ; 00-399025L , Lot Number 23JLA541 ; 00-399025L , Lot Number 23KLA374 ; 00-399227G , Lot Number 21FBH746 ; 00-399227G , Lot Number 21HBQ582 ; 00-399227G , Lot Number 21KBJ142 ; 00-399227G , Lot Number 21LBA848 ; 00-399227G , Lot Number 19ABX389 ; 00-399227G , Lot Number 22OBD945 ; 00-399227G , Lot Number 19FBF786 ; 00-399227G , Lot Number 19FBV846 ; 00-399227G , Lot Number 22HBG087 ; 00-399227G , Lot Number 19HBD311 ; 00-399227G , Lot Number 22JBP132 ; 00-399227G , Lot Number 19IBR526 ; 00-399227G , Lot Number 19KBL802 ; 00-399227G , Lot Number 23CBG549 ; 00-399227G , Lot Number 19LBY409 ; 00-399227G , Lot Number 20ABD605 ; 00-399227G , Lot Number 23FBQ709 ; 00-399227G , Lot Number 20CBV379 ; 00-399227G , Lot Number 23HBW465 ; 00-399227G , Lot Number 20EBL397 ; 00-399227G , Lot Number 20GBW360 ; 00-399227G , Lot Number 20JBJ256 ; 00-399227G , Lot Number 20VBB916 ; 00-399227G , Lot Number 21ABG945 ; 00-399227G , Lot Number 21EBA473 ; 00-399607N, Lot Number 24BME638; 00-399607N , Lot Number 21FBQ697 ; 00-399607N , Lot Number 21HBF930 ; 00-399607N , Lot Number 21IBK326 ; 00-399607N , Lot Number 21IBK327 ; 00-399607N , Lot Number 22BBP057 ; 00-399607N , Lot Number 19BBE379 ; 00-399607N , Lot Number 19BBG294 ; 00-399607N , Lot Number 22DBE564 ; 00-399607N , Lot Number 19DBF156 ; 00-399607N , Lot Number 19EBD546 ; 00-399607N , Lot Number 22FBI051 ; 00-399607N , Lot Number 19EBQ718 ; 00-399607N , Lot Number 19FBU662 ; 00-399607N , Lot Number 19GBL581 ; 00-399607N , Lot Number 22HBZ204 ; 00-399607N , Lot Number 22JBJ129 ; 00-399607N , Lot Number 19IBH297 ; 00-399607N , Lot Number 19IBZ735 ; 00-399607N , Lot Number 19VBC702 ; 00-399607N , Lot Number 19VBG151 ; 00-399607N , Lot Number 23ABS680 ; 00-399607N , Lot Number 19KBR370 ; 00-399607N , Lot Number 19KBW839 ; 00-399607N , Lot Number 19LBK459 ; 00-399607N , Lot Number 23DBR467 ; 00-399607N , Lot Number 23FBG342 ; 00-399607N , Lot Number 20BBX536 ; 00-399607N , Lot Number 23HBC816 ; 00-399607N , Lot Number 20DBN717 ; 00-399607N , Lot Number 23IBG758 ; 00-399607N , Lot Number 20FBF254 ; 00-399607N , Lot Number 23KBM922 ; 00-399607N , Lot Number 20HBO924 ; 00-399607N , Lot Number 20JBH212 ; 00-399607N , Lot Number 20XBI689 ; 00-399607N , Lot Number 21CBU874 ; 00-399607N , Lot Number 21DBB347 ; 00-399607N , Lot Number 23LMG018 ; 00-400616J , Lot Number 21JBQ238 ; 00-400616J , Lot Number 21KBM208 ; 00-400616J , Lot Number 21LBQ198 ; 00-400616J , Lot Number 21LBQ199 ; 00-400616J , Lot Number 19ABC535 ; 00-400616J , Lot Number 19ABQ477 ; 00-400616J , Lot Number 19BBT275 ; 00-400616J , Lot Number 19EBJ953 ; 00-400616J , Lot Number 22FBX768 ; 00-400616J , Lot Number 19GBA150 ; 00-400616J , Lot Number 22IBJ517 ; 00-400616J , Lot Number 22JBS696 ; 00-400616J , Lot Number 19IBJ031 ; 00-400616J , Lot Number 22KBS745 ; 00-400616J , Lot Number 22LBL785 ; 00-400616J , Lot Number 19JBT508 ; 00-400616J , Lot Number 19LBA785 ; 00-400616J , Lot Number 23CBX354 ; 00-400616J , Lot Number 23EBW479 ; 00-400616J , Lot Number 20BBR220 ; 00-400616J , Lot Number 20EBO092 ; 00-400616J , Lot Number 23JBA018 ; 00-400616J , Lot Number 23KBO018 ; 00-400616J , Lot Number 23LBJ675 ; 00-400616J , Lot Number 20LBI288 ; 00-400
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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