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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3004-2024

Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239; 5) US BREAST BIOPSY TRAY, Pack Number DYNDH1187A; 6) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286A; 7) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286AH; 8) PACK,BREAST BIOPSY, Pack Number DYNDL1498; 9) BONE MARROW PACK, Pack Number DYNJ0628436I ; 10) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035K; 11) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035KH; 12) OPP MINOR PACK-LF , Pack Number DYNJ0706869I ; 13) OPP MINOR PACK-LF , Pack Number DYNJ0706869IH; 14) BIOPSY DRAPE PACK , Pack Number DYNJ20953F ; 15) STEREOTACTIC TRAY , Pack Number DYNJ28856D ; 16) BIOPSY TRAY , Pack Number DYNJ31585C ; 17) BONE MARROW KIT PK, Pack Number DYNJ37526; 18) CT BIOPSY PACK-LF , Pack Number DYNJ38414B ; 19) CUSTOM BONE CEMENT TRAY-LF, Pack Number DYNJ42702D ; 20) LIVER TRANSPLANT PACK , Pack Number DYNJ43493A ; 21) BIOPSY TRAY , Pack Number DYNJ49368; 22) BONE MARROW HARVEST PACK, Pack Number DYNJ50740A ; 23) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550; 24) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550A ; 25) NDN CUSTOM BONE RECOVERY, Pack Number DYNJ903942D; 26) MODULE BREAST BIOPSY, Pack Number DYNJ904158B; 27) PACK,FETOSCOPY, Pack Number DYNJ906905B; 28) MINOR/BREAST BIOPSY-LF, Pack Number DYNJS3035; 29) BREAST BIOPSY-LF, Pack Number DYNJT1911D ; 30) BIOPSY TRAY , Pack Number SPEC0150 ; 31) BIOPSY TRAY W/O LIDOCAINE , Pack Number SPEC0196B; 32) STEREOTACTIC BIOPSY TRAY, Pack Number SPEC0279

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
CDS840215O , Lot Number 21HBJ135 ; CDS840215O , Lot Number 21JBS174 ; CDS840215O , Lot Number 22ABB090 ; CDS840215O , Lot Number 22ABS124 ; CDS840215O , Lot Number 22EBA066 ; CDS840215O , Lot Number 22GBQ007 ; CDS840215O , Lot Number 22GBQ009 ; CDS840215O , Lot Number 22HBU942 ; CDS840215O , Lot Number 23ABD369 ; CDS840215O , Lot Number 23CBO683 ; CDS840215O , Lot Number 23FBT988 ; CDS840215O , Lot Number 23GBI919 ; CDS840215O , Lot Number 23JBK910 ; CDS840215O , Lot Number 24ABE598 ; CDS840215O , Lot Number 20LBA006 ; CDS840215O , Lot Number 21ABQ774 ; CDS840215O , Lot Number 21ABR763 ; CDS840215O , Lot Number 21ABT392 ; CDS840215O , Lot Number 21CBM879 ; CDS840215O , Lot Number 21CBY329 ; CDS840215O , Lot Number 21DBP547 ; CDS981237F , Lot Number 19BBH974 ; CDS981237F , Lot Number 19DBZ760 ; CDS981237F , Lot Number 19GBG896 ; CDS981237F , Lot Number 19GBR697 ; CDS981237F , Lot Number 19IBK312 ; CDS981237F , Lot Number 19JBS472 ; CDS981237F , Lot Number 19VBE313 ; CDS981237F , Lot Number 19LBQ636 ; CDS981237F , Lot Number 20BBS514 ; DYNDA1217A , Lot Number 21JBQ356 ; DYNDC2239, Lot Number 21JBL152 ; DYNDH1187A, Lot Number 22HMH338; DYNDH1187A, Lot Number 22FMA363; DYNDH1187A, Lot Number 22EBC538; DYNDH1187A, Lot Number 22OBA249; DYNDH1187A, Lot Number 22BBZ459; DYNDH1187A, Lot Number 22HMH338; DYNDH1187A, Lot Number 22FMA363; DYNDH1187A, Lot Number 22EBC538; DYNDH1187A, Lot Number 22OBA249; DYNDH1187A, Lot Number 22BBZ459; DYNDH1286A, Lot Number 23FMA562; DYNDH1286A, Lot Number 23DME451; DYNDH1286A, Lot Number 23AMH934; DYNDH1286A , Lot Number 23JMC410 ; DYNDH1286AH, Lot Number 23FMA562; DYNDH1286AH, Lot Number 23DME451; DYNDH1286AH, Lot Number 23AMH934; DYNDH1286AH, Lot Number 23JMC410 ; DYNDL1498, Lot Number 21JBM328 ; DYNJ0628436I , Lot Number 20CDA324 ; DYNJ0628436I , Lot Number 20DDB806 ; DYNJ0628436I , Lot Number 20FDA658 ; DYNJ0628436I , Lot Number 20IDB329 ; DYNJ0628436I , Lot Number 20LDC229 ; DYNJ0628436I , Lot Number 21ADA277 ; DYNJ0628436I , Lot Number 21DDB241 ; DYNJ0628436I , Lot Number 21IDA223 ; DYNJ0628436I , Lot Number 21IDB517 ; DYNJ0628436I , Lot Number 21JDA063 ; DYNJ0628436I , Lot Number 21JDA834 ; DYNJ0628436I , Lot Number 21JDB718 ; DYNJ0660035K, Lot Number 24ALA341; DYNJ0660035K, Lot Number 23GLA731; DYNJ0660035K, Lot Number 23DLA072; DYNJ0660035KH, Lot Number 24ALA341; DYNJ0660035KH, Lot Number 23GLA731; DYNJ0660035KH, Lot Number 23DLA072; DYNJ0706869I , Lot Number 20JMC336 ; DYNJ0706869I , Lot Number 20LMD691 ; DYNJ0706869I , Lot Number 21DME377 ; DYNJ0706869I , Lot Number 21FMD242 ; DYNJ0706869I , Lot Number 21LMC086 ; DYNJ0706869I , Lot Number 22AMC817 ; DYNJ0706869I , Lot Number 22DME371 ; DYNJ0706869I , Lot Number 22EMD666 ; DYNJ0706869I , Lot Number 22FMA242 ; DYNJ0706869I , Lot Number 22GMD755 ; DYNJ0706869I , Lot Number 22IMB513 ; DYNJ0706869I , Lot Number 22IMB656 ; DYNJ0706869I , Lot Number 22LMA106 ; DYNJ0706869I , Lot Number 23BMG720 ; DYNJ0706869I , Lot Number 23DMB102 ; DYNJ0706869I , Lot Number 23EMI240 ; DYNJ0706869I , Lot Number 23FMH902 ; DYNJ0706869I , Lot Number 23HMC291 ; DYNJ0706869I , Lot Number 23IMG874 ; DYNJ0706869I , Lot Number 23JMG263 ; DYNJ0706869I , Lot Number 23KMI951 ; DYNJ0706869I , Lot Number 19AKC096 ; DYNJ0706869I , Lot Number 19BKC989 ; DYNJ0706869I , Lot Number 19DKA116 ; DYNJ0706869I , Lot Number 19EKA641 ; DYNJ0706869I , Lot Number 19FKB385 ; DYNJ0706869I , Lot Number 19HKA718 ; DYNJ0706869I , Lot Number 19IKA169 ; DYNJ0706869I , Lot Number 19KKC060 ; DYNJ0706869I , Lot Number 20BKB668 ; DYNJ0706869I , Lot Number 20EKA822 ; DYNJ0706869I , Lot Number 20HKA809 ; DYNJ0706869IH, Lot Number 21DME377 ; DYNJ0706869IH, Lot Number 21FMD242 ; DYNJ0706869IH, Lot Number 19AKC096 ; DYNJ0706869IH, Lot Number 19BKC989 ; DYNJ0706869IH, Lot Number 21LMC086 ; DYNJ0706869IH, Lot Number 19DKA116 ; DYNJ0706869IH, Lot Number 19EKA641 ; DYNJ0706869IH, Lot Number 19FKB385 ; DY
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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