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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3052-2024

Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP , Pack Number BM200A ; 4) SHOULDER ARTHROSCOPY, Pack Number BM230A ; 5) KNEE ARTHROSCOPY, Pack Number BM240A ; 6) PODIATRY PACK , Pack Number BM250A ; 7) CRANIOTOMY CDS, Pack Number CDS780025AA; 8) CRANIOTOMY CDS, Pack Number CDS780025AB; 9) CRANIOTOMY CDS, Pack Number CDS780025AC; 10) CRANIOTOMY CDS, Pack Number CDS780025X ; 11) CRANIOTOMY CDS, Pack Number CDS780025Y ; 12) LAMINECTOMY CDS-LF, Pack Number CDS780045M ; 13) LAMINECTOMY CDS-LF, Pack Number CDS780045N ; 14) LAMINECTOMY CDS-LF, Pack Number CDS780045O ; 15) CRANIOTOMY CDS, Pack Number CDS780046O ; 16) CRANI , Pack Number CDS780089V ; 17) CRANI , Pack Number CDS780089W ; 18) CRANI , Pack Number CDS780089X ; 19) CRANIOFACIAL CDS, Pack Number CDS780102K ; 20) CRANIOFACIAL CDS, Pack Number CDS780102L ; 21) TRAUMA/LIVER CDS-LF , Pack Number CDS780104L ; 22) CRANIOTOMY CDS-LF , Pack Number CDS780105K ; 23) CRANIOTOMY CDS-LF , Pack Number CDS780105L ; 24) NEURO LAMINECTOMY-LF, Pack Number CDS780109P ; 25) CRANIOTOMY-LF , Pack Number CDS780111M ; 26) CRANIOTOMY-LF , Pack Number CDS780111N ; 27) CRANIOTOMY-LF , Pack Number CDS780111O ; 28) CRANIOTOMY-LF , Pack Number CDS780111P ; 29) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119U ; 30) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119V ; 31) NEURO CRANIOTOMY CDS #36-RF , Pack Number CDS780119VH; 32) BASIC BACK CDS, Pack Number CDS780147K ; 33) INSTRUMENTED BACK CDS , Pack Number CDS780148O ; 34) LAMINECTOMY CDS , Pack Number CDS780165L ; 35) LAMINECTOMY CDS , Pack Number CDS780165M ; 36) LAMINECTOMY CDS , Pack Number CDS780165N ; 37) LAMINECTOMY CDS , Pack Number CDS780165O ; 38) LAMINECTOMY CDS , Pack Number CDS780165Q ; 39) LAMINECTOMY CDS , Pack Number CDS780165R ; 40) CRANIOTOMY CDS, Pack Number CDS780166Q ; 41) CRANIOTOMY CDS, Pack Number CDS780166R ; 42) CRANIOTOMY CDS, Pack Number CDS780166S ; 43) CRANIOTOMY CDS, Pack Number CDS780166T ; 44) CRANIOTOMY CDS, Pack Number CDS780166U ; 45) CRANIOTOMY CDS, Pack Number CDS780166V ; 46) DR WOLF SPINE CDS , Pack Number CDS780168P ; 47) GLENNON POSTERIOR SPINE FUSION, Pack Number CDS780182O ; 48) SPINAL FUSION CDS , Pack Number CDS780197N ; 49) SPINAL FUSION PACK, Pack Number CDS780197P ; 50) SPINAL FUSION PACK, Pack Number CDS780197Q ; 51) CRANIOT CRANIECT CDS, Pack Number CDS780201N ; 52) LAMINECTOMY CDS , Pack Number CDS780203J ; 53) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204P ; 54) SPINAL CARE LAMINECTOMY CDS , Pack Number CDS780204Q ; 55) ANTERIOR CERVICAL CDS , Pack Number CDS780205O ; 56) ANTERIOR CERVICAL CDS , Pack Number CDS780205P ; 57) ANTERIOR CERVICAL CDS , Pack Number CDS780205Q ; 58) CRANIOTOMY CDS, Pack Number CDS780206O ; 59) CRANIOTOMY CDS, Pack Number CDS780206P ; 60) CRANIOTOMY CDS, Pack Number CDS780206R ; 61) ANTERIOR LUMBAR CDS , Pack Number CDS780207S ; 62) ANTERIOR LUMBAR CDS , Pack Number CDS780207T ; 63) NEURO-LAMI CDS, Pack Number CDS780208I ; 64) CRANIOTOMY PROCEDURE, Pack Number CDS780210I ; 65) CRANIOTOMY PROCEDURE, Pack Number CDS780210J ; 66) CRANIOTOMY PROCEDURE, Pack Number CDS780210K ; 67) SPINE CDS , Pack Number CDS780228D ; 68) LAMINECTOMY CDS-LF, Pack Number CDS780235V ; 69) LAMINECTOMY CDS-LF, Pack Number CDS780235W ; 70) LAMINECTOMY CDS-LF, Pack Number CDS780235X ; 71) SPINE CDS-LF, Pack Number CDS780236L ; 72) SPINE CDS-LF, Pack Number CDS780236M ; 73) CRANIOTOMY CDS-LF , Pack Number CDS780237K ; 74) CRANIOTOMY CDS-LF , Pack Number CDS780237L ; 75) SPINAL FUSION , Pack Number CDS860017AA; 76) SPINAL FUSION , Pack Number CDS860017AB; 77) SPINAL FUSION , Pack Number CDS860017AC; 78) FUSION CDS, Pack Number CDS860138D ; 79) FUSION CDS, Pack Number CDS860138F ; 80) FUSION CDS, Pack Number CDS860138G ; 81) LUMBAR, Pack Number CDS860170I ; 82) LUMBAR, Pack Number CDS860170J ; 83) LUMBAR, Pack Numbe

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
00-399024X , Lot Number 19CBL066 ; 00-399024X , Lot Number 19FBI397 ; 00-399024X , Lot Number 19RBC685 ; 00-399024X , Lot Number 19HBD864 ; 00-399024X , Lot Number 19JBV149 ; 00-399024X , Lot Number 20ABH766 ; 00-399024X , Lot Number 20ABO115 ; 00-399024X , Lot Number 20CBC862 ; AM110A , Lot Number 21GBK629 ; AM110A , Lot Number 19HBC424 ; AM110A , Lot Number 19JBR312 ; AM110A , Lot Number 19KBL415 ; AM110A , Lot Number 20ABK847 ; AM110A , Lot Number 20GBU689 ; AM110A , Lot Number 20HBK170 ; AM110A , Lot Number 20LBN052 ; AM110A , Lot Number 20LBW697 ; AM110A , Lot Number 21CBB960 ; AM110A , Lot Number 21FBC989 ; BM200A , Lot Number 19EBU942 ; BM230A , Lot Number 22CBC356 ; BM230A , Lot Number 19DBJ049 ; BM230A , Lot Number 19UBA244 ; BM230A , Lot Number 19JBQ486 ; BM230A , Lot Number 20DBF398 ; BM230A , Lot Number 20IBB552 ; BM230A , Lot Number 20JBR898 ; BM240A , Lot Number 21IBR974 ; BM240A , Lot Number 22BBC921 ; BM240A , Lot Number 19CBF549 ; BM240A , Lot Number 19EBV048 ; BM240A , Lot Number 20DBS054 ; BM240A , Lot Number 20GBU725 ; BM240A , Lot Number 20KBS381 ; BM240A , Lot Number 20KBX781 ; BM240A , Lot Number 21BBJ873 ; BM240A , Lot Number 21DBI364 ; BM250A , Lot Number 21LBI573 ; BM250A , Lot Number 22EBQ666 ; BM250A , Lot Number 19HBG435 ; BM250A , Lot Number 19JBD740 ; BM250A , Lot Number 20ABK834 ; BM250A , Lot Number 20DBR991 ; BM250A , Lot Number 20EBT982 ; BM250A , Lot Number 20GBC494 ; BM250A , Lot Number 20GBN979 ; BM250A , Lot Number 23LBT030 ; BM250A , Lot Number 20KBA693 ; BM250A , Lot Number 21ABA267 ; BM250A , Lot Number 21ABF688 ; BM250A , Lot Number 21BBM607 ; CDS780025AA, Lot Number 21ABG344 ; CDS780025AA, Lot Number 21BBI957 ; CDS780025AA, Lot Number 21CBD927 ; CDS780025AB, Lot Number 21HBL624 ; CDS780025AB, Lot Number 21IBL720 ; CDS780025AB, Lot Number 21LBU758 ; CDS780025AB, Lot Number 22CBP174 ; CDS780025AB, Lot Number 22EBN090 ; CDS780025AB, Lot Number 22GBH493 ; CDS780025AB, Lot Number 22HBB637 ; CDS780025AC, Lot Number 22LBF788 ; CDS780025AC, Lot Number 23CBX130 ; CDS780025AC, Lot Number 23EBJ659 ; CDS780025AC, Lot Number 23FBH173 ; CDS780025AC, Lot Number 23IBI612 ; CDS780025AC, Lot Number 23KBC083 ; CDS780025AC, Lot Number 24BBB443 ; CDS780025X , Lot Number 19ABP155 ; CDS780025X , Lot Number 19ABQ093 ; CDS780025X , Lot Number 19ABY942 ; CDS780025X , Lot Number 19CBE111 ; CDS780025X , Lot Number 19FBV023 ; CDS780025Y , Lot Number 19EBO302 ; CDS780025Y , Lot Number 19EBO396 ; CDS780025Y , Lot Number 19KBQ760 ; CDS780025Y , Lot Number 19KBU716 ; CDS780025Y , Lot Number 19LBF130 ; CDS780025Y , Lot Number 20DBO129 ; CDS780025Y , Lot Number 20GBQ281 ; CDS780025Y , Lot Number 20GBS047 ; CDS780025Y , Lot Number 20JBY248 ; CDS780045M , Lot Number 19BBH900 ; CDS780045M , Lot Number 19CBC615 ; CDS780045M , Lot Number 19DBC309 ; CDS780045M , Lot Number 19EBU628 ; CDS780045M , Lot Number 19EBU835 ; CDS780045M , Lot Number 19GBR400 ; CDS780045M , Lot Number 19SBC898 ; CDS780045M , Lot Number 19VBE307 ; CDS780045M , Lot Number 19KBN002 ; CDS780045M , Lot Number 19KBT829 ; CDS780045M , Lot Number 20BBJ961 ; CDS780045M , Lot Number 20CBP221 ; CDS780045N , Lot Number 21FBL891 ; CDS780045N , Lot Number 21FBS507 ; CDS780045N , Lot Number 21JBU289 ; CDS780045N , Lot Number 21LBP574 ; CDS780045N , Lot Number 22DBA187 ; CDS780045N , Lot Number 22DBB694 ; CDS780045N , Lot Number 22FBM376 ; CDS780045N , Lot Number 22GBG444 ; CDS780045N , Lot Number 22GBG445 ; CDS780045N , Lot Number 22JBI816 ; CDS780045N , Lot Number 22JBI817 ; CDS780045N , Lot Number 22LBP661 ; CDS780045N , Lot Number 23CBR748 ; CDS780045N , Lot Number 20GBC500 ; CDS780045N , Lot Number 20GBD251 ; CDS780045N , Lot Number 20GBL415 ; CDS780045N , Lot Number 20GBQ383 ; CDS780045N , Lot Number 20IBN736 ; CDS780045N , Lot Number 20JBX378 ; CDS780045N , Lot Number 20LBC750 ; CDS780045N , Lot Number 21BBF167 ; CDS780045O , Lot Number 23DBP671
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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