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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3050-2024

Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number CDS981757P ; 5) GYN ROBOTIC , Pack Number CDS981826J ; 6) ROBOTIC CDS , Pack Number CDS981882Q ; 7) ROBOTIC CDS , Pack Number CDS981882R ; 8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ; 9) D&C CDS-WRMC, Pack Number CDS982331N ; 10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ; 11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ; 12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ; 13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ; 14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ; 15) GYN/ABDOMINAL , Pack Number CDS982725M ; 16) ROBOTIC CDS , Pack Number CDS982888D ; 17) ROBOTIC CDS , Pack Number CDS982888F ; 18) ROBOTIC CDS , Pack Number CDS982888G ; 19) ROBOTIC CDS , Pack Number CDS983028D ; 20) ZALE PUMP CDS , Pack Number CDS983187F ; 21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ; 22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ; 23) ROBOTIC CDS-LF, Pack Number CDS983258O ; 24) ROBOTIC CDS-LF, Pack Number CDS983258Q ; 25) VAGINAL MINOR , Pack Number CDS983268K ; 26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ; 27) ROBOTIC CDS , Pack Number CDS983399D ; 28) GYN VAGINAL CDS , Pack Number CDS983528L ; 29) GYN VAGINAL CDS , Pack Number CDS983528M ; 30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ; 31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ; 32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ; 33) OB CDS, Pack Number CDS983854B ; 34) OB/GYN CDS, Pack Number CDS984173F ; 35) GROTH VAGINAL , Pack Number CDS984201V ; 36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ; 37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ; 38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ; 39) GYN CDS , Pack Number CDS984860G ; 40) OB DELIVERY CDS , Pack Number CDS985027I ; 41) OB/GYN CDS RICE , Pack Number CDS985256C ; 42) OB/GYN CDS RICE , Pack Number CDS985256D ; 43) OB/GYN CDS RICE , Pack Number CDS985256F ; 44) OB CDS-LF , Pack Number CDS985320C ; 45) OB, Pack Number CDS985506D ; 46) OB, Pack Number CDS985506F ; 47) OB, Pack Number CDS985506G ; 48) OB, Pack Number CDS985506I ; 49) GYN LAPAROSCOPY , Pack Number CDS985519L ; 50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ; 51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ; 52) PERI-GYN PACK-LF, Pack Number DYNJ0038057; 53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ; 54) DAVINCI PACK-LF , Pack Number DYNJ0042750; 55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ; 56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ; 57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ; 58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ; 59) D AND C PACK-LF , Pack Number DYNJ0161028C ; 60) D AND C PACK-LF , Pack Number DYNJ0161028F ; 61) D AND C PACK-LF , Pack Number DYNJ0161028G ; 62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ; 63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ; 64) ROBOT PACK, Pack Number DYNJ01823F ; 65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ; 66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ; 67) OB PACK , Pack Number DYNJ03387A ; 68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ; 69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ; 70) OB PACK-LF, Pack Number DYNJ0367126L ; 71) OB PACK-LF, Pack Number DYNJ0367126M ; 72) OB PACK-LF, Pack Number DYNJ0367126N ; 73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ; 74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ; 75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ; 76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ; 77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ; 78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ; 79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ; 80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ; 81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ

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
CDS830039AD, Lot Number 19CBH292 ; CDS830039AD, Lot Number 19PBC608 ; CDS840214P , Lot Number 21FBN852 ; CDS840214P , Lot Number 21HBB376 ; CDS840214P , Lot Number 21HBF491 ; CDS840214P , Lot Number 21IBO111 ; CDS840214P , Lot Number 22ABD314 ; CDS840214P , Lot Number 22BBI956 ; CDS840214P , Lot Number 22HBP289 ; CDS840214P , Lot Number 22IBO308 ; CDS840214P , Lot Number 22IBR971 ; CDS840214P , Lot Number 22KBN497 ; CDS840214P , Lot Number 20JBQ048 ; CDS840214P , Lot Number 20KBG189 ; CDS840214P , Lot Number 20KBY177 ; CDS840214P , Lot Number 21BBC946 ; CDS981335C , Lot Number 21GBL170 ; CDS981335C , Lot Number 21HBB530 ; CDS981335C , Lot Number 21WBA896 ; CDS981335C , Lot Number 22NBC853 ; CDS981335C , Lot Number 22OBB104 ; CDS981335C , Lot Number 22IBP869 ; CDS981335C , Lot Number 20GBI170 ; CDS981335C , Lot Number 20KBR144 ; CDS981335C , Lot Number 21BBE035 ; CDS981335C , Lot Number 21BBL646 ; CDS981335C , Lot Number 21EBH220 ; CDS981757P , Lot Number 21FMB526 ; CDS981757P , Lot Number 21FMD778 ; CDS981757P , Lot Number 21GMB729 ; CDS981757P , Lot Number 21HMF534 ; CDS981757P , Lot Number 21KMD539 ; CDS981757P , Lot Number 21LMC014 ; CDS981757P , Lot Number 22AMF312 ; CDS981757P , Lot Number 20HKC001 ; CDS981757P , Lot Number 20LKA498 ; CDS981757P , Lot Number 21DKA317 ; CDS981757P , Lot Number 21EKA037 ; CDS981826J , Lot Number 21FBR364 ; CDS981826J , Lot Number 21IBE988 ; CDS981826J , Lot Number 21VBB532 ; CDS981826J , Lot Number 21LBO570 ; CDS981826J , Lot Number 21LBO574 ; CDS981826J , Lot Number 22CBA147 ; CDS981826J , Lot Number 19ABX512 ; CDS981826J , Lot Number 19CBO432 ; CDS981826J , Lot Number 22DBM116 ; CDS981826J , Lot Number 22EBB425 ; CDS981826J , Lot Number 19EBK468 ; CDS981826J , Lot Number 22GBU016 ; CDS981826J , Lot Number 19FBW726 ; CDS981826J , Lot Number 22HBN374 ; CDS981826J , Lot Number 22IBA569 ; CDS981826J , Lot Number 19HBD972 ; CDS981826J , Lot Number 22JBI776 ; CDS981826J , Lot Number 19IBD508 ; CDS981826J , Lot Number 22KBD576 ; CDS981826J , Lot Number 19IBP473 ; CDS981826J , Lot Number 22LBM177 ; CDS981826J , Lot Number 23ABL468 ; CDS981826J , Lot Number 19KBT872 ; CDS981826J , Lot Number 19LBY107 ; CDS981826J , Lot Number 23DBT137 ; CDS981826J , Lot Number 23EBK904 ; CDS981826J , Lot Number 23EBW563 ; CDS981826J , Lot Number 20BBQ533 ; CDS981826J , Lot Number 23FBL903 ; CDS981826J , Lot Number 20CBC257 ; CDS981826J , Lot Number 23GBP568 ; CDS981826J , Lot Number 20FBA574 ; CDS981826J , Lot Number 23IBU308 ; CDS981826J , Lot Number 23IBW118 ; CDS981826J , Lot Number 23KBL301 ; CDS981826J , Lot Number 20HBU183 ; CDS981826J , Lot Number 24CBA387 ; CDS981826J , Lot Number 24CBG312 ; CDS981826J , Lot Number 20KBT694 ; CDS981826J , Lot Number 20LBR755 ; CDS981826J , Lot Number 20LBU444 ; CDS981826J , Lot Number 21BBD223 ; CDS981826J , Lot Number 21BBR536 ; CDS981826J , Lot Number 21CBO855 ; CDS981826J , Lot Number 21CBR551 ; CDS981882Q , Lot Number 19PBB582 ; CDS981882Q , Lot Number 19GBP429 ; CDS981882Q , Lot Number 19HBR905 ; CDS981882Q , Lot Number 19JBQ808 ; CDS981882R , Lot Number 19JBS122 ; CDS981882R , Lot Number 19LBF118 ; CDS981984I , Lot Number 21IBP860 ; CDS981984I , Lot Number 21KBD858 ; CDS981984I , Lot Number 19BBK784 ; CDS981984I , Lot Number 19BBR887 ; CDS981984I , Lot Number 19CBI615 ; CDS981984I , Lot Number 22OBI060 ; CDS981984I , Lot Number 19EBQ351 ; CDS981984I , Lot Number 22HBF738 ; CDS981984I , Lot Number 22IBN140 ; CDS981984I , Lot Number 19HBK974 ; CDS981984I , Lot Number 22JBP284 ; CDS981984I , Lot Number 22KBF154 ; CDS981984I , Lot Number 23ABH884 ; CDS981984I , Lot Number 23ABT088 ; CDS981984I , Lot Number 23BBU118 ; CDS981984I , Lot Number 23BBU913 ; CDS981984I , Lot Number 23CBM167 ; CDS981984I , Lot Number 20ABG963 ; CDS981984I , Lot Number 23EBN576 ; CDS981984I , Lot Number 20BBI298 ; CDS981984I , Lot Number 23GBW025 ; CDS981984I , Lot Number 20DBG987 ; CDS9
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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