FDAFDA · Alimentos y medicamentos·N.º oficial Z-2998-2024
Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J; 2) BIOPSY PROCEDURE TRAY , Pack Number 00-400405C ; 3) BIOPSY DRAPE PACK , Pack Number 00-400762H ; 4) BIOPSY PROCEDURE PACK , Pack Number 00-400832N ; 5) BIOPSY PROCEDURE PACK , Pack Number 00-400832O ; 6) BIOPSY PROCEDURE PACK , Pack Number 00-400832P ; 7) BIOPSY PROCEDURE PACK , Pack Number 00-401261F ; 8) 6" FEMORAL ARTERIALLINE KIT, Pack Number ART245B; 9) BREAST BIOPSY KIT , Pack Number BT1085A; 10) BREAST BIOPSY PROCEDURE TRAY, Pack Number BX8375F; 11) BREAST/MINOR, Pack Number CDS980228X ; 12) BIOPSY CDS-LF , Pack Number CDS984667D ; 13) BIOPSY CDS-LF , Pack Number CDS984667F ; 14) BREAST-HERNIA-PORT CDS-LF , Pack Number CDS984853G ; 15) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 16) QSUM STEREO/US BIOPSY TRAY, Pack Number CT101; 17) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960; 18) BIOPSY DEKALB PACK, Pack Number DM150A ; 19) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 20) COLONOSCOPY KIT , Pack Number DYKE1218 ; 21) BREAST BIOPSY KIT , Pack Number DYNDA1224B ; 22) TDC REMOVAL, Pack Number DYNDA1633A; 23) BREAST BIOPSY PACK, Pack Number DYNDA2378A ; 24) CUSTOM BIOPSY TRAY, Pack Number DYNDA2448; 25) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 26) BIOPSY/MYELOGRAM PACK, Pack Number DYNDA2655; 27) PICU LINE TRAY, Pack Number DYNDC1960A; 28) PORT ACCESS KIT, Pack Number DYNDC2945; 29) CT BIOPSY TRAY, Pack Number DYNDH1054; 30) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 31) BIOPSY PACK , Pack Number DYNDH1110; 32) ARTHROGRAM TRAY, Pack Number DYNDH1113; 33) BIOPSY TRAY , Pack Number DYNDH1114; 34) BIOPSY TRAY, Pack Number DYNDH1129; 35) ARTHROGRAM TRAY, Pack Number DYNDH1134; 36) BIOPSY PACK , Pack Number DYNDH1137A ; 37) BREAST BIOPSY TRAY, Pack Number DYNDH1142C ; 38) BREAST BIOPSY TRAY, Pack Number DYNDH1152A ; 39) BIOPSY KIT, Pack Number DYNDH1156; 40) ULTRASOUND TRAY, Pack Number DYNDH1204; 41) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 42) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 43) CORE BIOPSY TRAY, Pack Number DYNDH1233; 44) BIOPSY PACK, Pack Number DYNDH1248; 45) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 46) BREAST BIOPSY TRAY, Pack Number DYNDH1266; 47) GENERAL BIOPSY TRAY , Pack Number DYNDH1268; 48) BIOPSY TRAY, Pack Number DYNDH1269; 49) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270; 50) DB CT BIOPSY TRAY -LF , Pack Number DYNDH1270; 51) BIOPSY TRAY , Pack Number DYNDH1273; 52) BIOPSY PACK TAA COMPLIANT , Pack Number DYNDH1294; 53) BREAST BIOPSY TRAY, Pack Number DYNDH1296B ; 54) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 55) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297; 56) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300; 57) BREAST BIOPSY TRAY, Pack Number DYNDH1302; 58) BREAST BIOPSY TRAY, Pack Number DYNDH1302H ; 59) BIOPSY TRAY, Pack Number DYNDH1314; 60) BIOPSY TRAY , Pack Number DYNDH1314A ; 61) MAMMOGRAPHY BREAST BIOPSY, Pack Number DYNDH1318; 62) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 63) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324; 64) BIOPSY TRAY, Pack Number DYNDH1328; 65) CT BIOPSY TRAY, Pack Number DYNDH1355A ; 66) BONE MARROW BIOPSY ASPIRATION , Pack Number DYNDH1376A ; 67) BREAST BIOPSY PACK, Pack Number DYNDH1425; 68) THYROID BIOPSY PACK , Pack Number DYNDH1430A ; 69) BONE MARROW BIOPSY KIT, Pack Number DYNDH1434; 70) SOFT TISSUE BIOPSY, Pack Number DYNDH1477; 71) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496A ; 72) ULTRASOUND BREAST BIOPSY, Pack Number DYNDH1496AH; 73) BREAST BIOPSY , Pack Number DYNDH1518A ; 74) BIOPSY, Pack Number DYNDH1543; 75) BIOPSY PACK , Pack Number DYNDH1556; 76) BIOPSY PACK , Pack Number DYNDH1556D ; 77) IR BIOPSY TRAY, Pack Number DYNDH1569; 78) BIOPSY KIT, Pack Number DYNDH1570; 79) STEREOTACTIC BIOPSY , Pack Number DYNDH1572; 80) ULTRASOUND BIOPSY , Pack Number DYNDH1573A ; 81) BREAST BIOPSY , Pack Number DYNDH1575; 82) CT BIOP
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
- 00-400162J, Lot Number 24BMJ154; 00-400162J , Lot Number 21HBM269 ; 00-400162J , Lot Number 21IBK734 ; 00-400162J , Lot Number 21VBB786 ; 00-400162J , Lot Number 21KBS936 ; 00-400162J , Lot Number 21LBA763 ; 00-400162J , Lot Number 22ABN222 ; 00-400162J , Lot Number 19ABM483 ; 00-400162J , Lot Number 19BBI451 ; 00-400162J , Lot Number 19CBM173 ; 00-400162J , Lot Number 19DBL959 ; 00-400162J , Lot Number 22FBO944 ; 00-400162J , Lot Number 19FBG533 ; 00-400162J , Lot Number 22JBB402 ; 00-400162J , Lot Number 19TBB201 ; 00-400162J , Lot Number 22KBV632 ; 00-400162J , Lot Number 19JBD745 ; 00-400162J , Lot Number 19KBI828 ; 00-400162J , Lot Number 19LBK452 ; 00-400162J , Lot Number 23CBO907 ; 00-400162J , Lot Number 19LBY367 ; 00-400162J , Lot Number 20ABQ389 ; 00-400162J , Lot Number 23FBG349 ; 00-400162J , Lot Number 20CBV380 ; 00-400162J , Lot Number 20DBI320 ; 00-400162J , Lot Number 23IBF372 ; 00-400162J , Lot Number 20FBQ675 ; 00-400162J , Lot Number 20GBO378 ; 00-400162J , Lot Number 20JBH095 ; 00-400162J , Lot Number 20JBL452 ; 00-400162J , Lot Number 20JBX151 ; 00-400162J , Lot Number 20KBZ223 ; 00-400162J , Lot Number 20XBA215 ; 00-400162J , Lot Number 21DBB680 ; 00-400162J , Lot Number 24AMB898 ; 00-400405C , Lot Number 21KBM812 ; 00-400405C , Lot Number 21LBT408 ; 00-400405C , Lot Number 21LBT899 ; 00-400405C , Lot Number 19ABL059 ; 00-400405C , Lot Number 19BBB783 ; 00-400405C , Lot Number 19CBC868 ; 00-400405C , Lot Number 19KBY105 ; 00-400405C , Lot Number 19LBB184 ; 00-400762H , Lot Number 21HBR227 ; 00-400832N , Lot Number 19BDA790 ; 00-400832N , Lot Number 19BDD147 ; 00-400832N , Lot Number 19DDB220 ; 00-400832N , Lot Number 19FDA964 ; 00-400832O , Lot Number 19IDA318 ; 00-400832O , Lot Number 19KMA743 ; 00-400832O , Lot Number 19KMC836 ; 00-400832O , Lot Number 20BMA017 ; 00-400832O , Lot Number 20CMB031 ; 00-400832O , Lot Number 20FMB526 ; 00-400832O , Lot Number 20HMC867 ; 00-400832O , Lot Number 20JMB320 ; 00-400832O , Lot Number 21AMC858 ; 00-400832O , Lot Number 21FMA865 ; 00-400832O , Lot Number 21HMB368 ; 00-400832O , Lot Number 21JMA868 ; 00-400832O , Lot Number 22AME715 ; 00-400832O , Lot Number 22CMA957 ; 00-400832P , Lot Number 23LBL872 ; 00-400832P , Lot Number 22EMF901 ; 00-400832P , Lot Number 22GMD199 ; 00-400832P , Lot Number 22HME947 ; 00-400832P , Lot Number 22JMA494 ; 00-400832P , Lot Number 22KMD610 ; 00-400832P , Lot Number 23AMB199 ; 00-400832P , Lot Number 23CMD961 ; 00-400832P , Lot Number 23EMD513 ; 00-400832P , Lot Number 23FMH541 ; 00-400832P , Lot Number 23GMH251 ; 00-400832P , Lot Number 23IMA234 ; 00-400832P , Lot Number 23KMA301 ; 00-401261F , Lot Number 19DDD151 ; ART245B, Lot Number 2023050490; BT1085A, Lot Number 21JBW716 ; BT1085A, Lot Number 22EBN971 ; BT1085A, Lot Number 22IBO409 ; BT1085A, Lot Number 22KBQ151 ; BT1085A, Lot Number 22LBS928 ; BT1085A, Lot Number 23EBQ469 ; BT1085A, Lot Number 23HBA899 ; BT1085A, Lot Number 23HBM503 ; BT1085A, Lot Number 23LBP500 ; BX8375F, Lot Number 19BBQ976 ; CDS980228X , Lot Number 21IBJ198 ; CDS980228X , Lot Number 21IBL102 ; CDS980228X , Lot Number 21IBT611 ; CDS980228X , Lot Number 21KBA518 ; CDS980228X , Lot Number 22CBT672 ; CDS980228X , Lot Number 22OBL706 ; CDS980228X , Lot Number 22EBN150 ; CDS980228X , Lot Number 22GBJ007 ; CDS980228X , Lot Number 22GBJ522 ; CDS980228X , Lot Number 22GBU493 ; CDS980228X , Lot Number 22HBO646 ; CDS980228X , Lot Number 22JBH336 ; CDS980228X , Lot Number 22KBI846 ; CDS980228X , Lot Number 23BBB687 ; CDS980228X , Lot Number 23BBB770 ; CDS980228X , Lot Number 23CBQ216 ; CDS980228X , Lot Number 23EBG155 ; CDS980228X , Lot Number 23FBH110 ; CDS980228X , Lot Number 23FBU678 ; CDS980228X , Lot Number 23HBK342 ; CDS980228X , Lot Number 23IBM309 ; CDS980228X , Lot Number 23KBN911 ; CDS980228X , Lot Number 23LBQ885 ; CDS980228X , Lot Number 24ABV909 ; CDS984667D , Lot Number 19ABX202 ; CDS984667D ,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.