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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3020-2024

Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 6) 18GX6" FEMORAL ART LINE KIT, Pack Number ART960A; 7) 20GX3" RADIAL ART LINE KIT, Pack Number ART970A; 8) BIOPSY TRAY, Pack Number BT1015; 9) BIOPSY TRAY, Pack Number BT1060; 10) STEREOTACTIC BREAST BIOPSY TRAY, Pack Number BT1095; 11) BIOPSY KIT, Pack Number BT450A ; 12) CHEST TUBE INSERTION TRAY , Pack Number CHT1020; 13) CHEST TUBE INSERTION KIT, Pack Number CHT1465; 14) CHEST TUBE INSERTION TRAY , Pack Number CHT2040; 15) CHEST TUBE INSERTION TRAY , Pack Number CHT2040H ; 16) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 17) CHEST TUBE INSERTION TRAY , Pack Number CHT701 ; 18) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 19) CIRCUMCISION TRAY, Pack Number CIT6260; 20) CIRCUMCISION TRAY, Pack Number CIT6325; 21) CIRCUMCISION TRAY , Pack Number CIT6575A ; 22) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 23) CHEST TUBE INSERTION TRAY , Pack Number CVI2105; 24) CHEST TUBE INSERTION TRAY , Pack Number CVI2105H ; 25) EXTREMITY PACK, Pack Number CVI4680; 26) CVC INSERTION PACK, Pack Number CVI4720; 27) VENOUS ACCESS TRAY, Pack Number CVI4830A; 28) VENOUS ACCESS TRAY, Pack Number CVI4830B; 29) MVHS CVC LUMEN TRAY, Pack Number CVI4920; 30) PEDS VASCULAR ACCESS KIT, Pack Number CVI4960A; 31) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 32) CATHETER ON/OFF KIT, Pack Number DT5490B; 33) CHEST TUBE, UMBI LINE PK, Pack Number DYNDA1432A; 34) BIOPSY KIT, Pack Number DYNDA1466A; 35) CUP KIT, Pack Number DYNDA1506; 36) DERMATOLOGY KIT, Pack Number DYNDA1567D; 37) TDC REMOVAL, Pack Number DYNDA1633A; 38) PAN MP TRACHEOSTOMY, Pack Number DYNDA1635; 39) PERM CATH, Pack Number DYNDA1732A; 40) CATH REMOVAL, Pack Number DYNDA1733B; 41) CATH REMOVAL, Pack Number DYNDA1814; 42) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 43) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 44) PORT TUNNEL CATH REMOVAL TRAY, Pack Number DYNDA2033A; 45) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 46) PULL D/C PACK, Pack Number DYNDA2080; 47) CONGENITAL ADD-ON KIT, Pack Number DYNDA2213A; 48) PAIN TRAY, Pack Number DYNDA2416; 49) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495; 50) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 51) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523; 52) ONCOLOGY-HEMOTOLOGY PREP TRAY-STERILE/LF, Pack Number DYNDA2523A; 53) GENERAL UTILITY, Pack Number DYNDA2524; 54) SHUNT TRAY, Pack Number DYNDA2725; 55) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 56) PICU LINE TRAY, Pack Number DYNDC1960A; 57) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 58) PORT ACCESS KIT, Pack Number DYNDC2945; 59) PRE POST DIALYSIS, Pack Number DYNDC3274; 60) BMA BX TRAY, Pack Number DYNDH1050A; 61) BONE MARROW TRAY - NO NEEDLE, Pack Number DYNDH1059; 62) BIOPSY PACK SM, Pack Number DYNDH1093; 63) PQ BIOPSY PACK (BPSJH), Pack Number DYNDH1108; 64) ARTHROGRAM TRAY, Pack Number DYNDH1113; 65) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 66) BIOPSY TRAY, Pack Number DYNDH1129; 67) ARTHROGRAM TRAY, Pack Number DYNDH1134; 68) BIOPSY PACK, Pack Number DYNDH1137A; 69) BIOPSY TRAY, Pack Number DYNDH1137C; 70) ARTHROGRAM PACK, Pack Number DYNDH1148; 71) ULTRASOUND TRAY, Pack Number DYNDH1204; 72) IR PICC TRAY, Pack Number DYNDH1223; 73) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 74) BIOPSY TRAY-LF, Pack Number DYNDH1229; 75) ARTHROGRAM TRAY, Pack Number DYNDH1243; 76) BIOPSY PACK, Pack Number DYNDH1248; 77) BONE MARROW BIOPSY TRAY, Pack Number DYNDH1251; 78) BREAST BIOPSY TRAY, Pack Number DYNDH1257; 79) BIOPSY TRAY, Pack Number DYNDH1269; 80) BIOPSY TRAY, Pack Number DYNDH1273; 81) FLUORO PROCEDURE TRAY, Pack Number DYNDH1276; 82) BONE MARROW

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
81239, Lot Number 24DDA646; 81239, Lot Number 24BDA159; 81239, Lot Number 24ADA118; 81239, Lot Number 23LDB385; 81239, Lot Number 23FDB922; 81239, Lot Number 23FDB435; 81239, Lot Number 23CDC570; 81239, Lot Number 23BDA790; 81239, Lot Number 23ADA161; 81239, Lot Number 22LDA211; 81239, Lot Number 22KDA441; 81239, Lot Number 22HDA985; 81239, Lot Number 22GDB017; 81239, Lot Number 22FDA642; 81239, Lot Number 22BDB971; 81239, Lot Number 22BDB067; 81239, Lot Number 22BDA725; 81239, Lot Number 21LDA117; 81239, Lot Number 21KDB172; 81239, Lot Number 21HDA966; 81239, Lot Number 21GDD227; 81239, Lot Number 21DDC268; 81239, Lot Number 21DDA425; 81239, Lot Number 21CDB386; 81239, Lot Number 21BDB285; 81239, Lot Number 21ADA073; 946279 , Lot Number 21BKA450 ; ART1165, Lot Number 2022081890; ART1165, Lot Number 2022111890; ART1165, Lot Number 2023071190; ART1165, Lot Number 2023083190; ART1165, Lot Number 2023092290; ART1165, Lot Number 2023110990; ART1165, Lot Number 2023122990; ART1165, Lot Number 2024031290; ART1210, Lot Number 2023080190; ART240B, Lot Number 2023112290; ART240B, Lot Number 2024031590; ART960A, Lot Number 2023082890; ART960A, Lot Number 2023092790; ART960A, Lot Number 2023112990; ART960A, Lot Number 2023122190; ART960A, Lot Number 2024020190; ART970A, Lot Number 2023082890; ART970A, Lot Number 2023120790; BT1015, Lot Number 2019031190; BT1015, Lot Number 2021030190; BT1015, Lot Number 2022030490; BT1060, Lot Number 2020010790; BT1060 , Lot Number 21HBS949 ; BT1060 , Lot Number 21IBP676 ; BT1060 , Lot Number 21KBR236 ; BT1060 , Lot Number 21LBF894 ; BT1060 , Lot Number 22ABX733 ; BT1060 , Lot Number 22FBK864 ; BT1060 , Lot Number 22KBP269 ; BT1060 , Lot Number 23EBD654 ; BT1060 , Lot Number 23FBP748 ; BT1060 , Lot Number 23KBC222 ; BT1060 , Lot Number 23LBL371 ; BT1060 , Lot Number 21ABF385 ; BT1060 , Lot Number 21ABT342 ; BT1060 , Lot Number 21BBO441 ; BT1060 , Lot Number 21CBV637 ; BT1095, Lot Number 2020020790; BT1095, Lot Number 2020022690; BT450A , Lot Number 21JBG947 ; CHT1020, Lot Number 21JBN310 ; CHT1465, Lot Number 21HBR240 ; CHT1465, Lot Number 21KBC516 ; CHT1465, Lot Number 22BBH387 ; CHT1465, Lot Number 22BBR031 ; CHT1465, Lot Number 22FBU118 ; CHT1465, Lot Number 21DBD915 ; CHT1465, Lot Number 22IMD540 ; CHT1465, Lot Number 23CMC009 ; CHT1465, Lot Number 23EMA144 ; CHT1465, Lot Number 23FMA800 ; CHT1465, Lot Number 23FME610 ; CHT1465, Lot Number 23FMF447 ; CHT1465, Lot Number 23HMB406 ; CHT1465, Lot Number 23HMD786 ; CHT1465, Lot Number 23IME835 ; CHT1465, Lot Number 23JMJ875 ; CHT1465, Lot Number 23KMI144 ; CHT2040, Lot Number 22HBM306 ; CHT2040, Lot Number 23HBC212 ; CHT2040, Lot Number 23HBS289 ; CHT2040, Lot Number 23IBE762 ; CHT2040H , Lot Number 22HBM306 ; CHT2040H , Lot Number 23HBC212 ; CHT2040H , Lot Number 23HBS289 ; CHT2040H , Lot Number 23IBE762 ; CHT560, Lot Number 2019073090; CHT560, Lot Number 2020080390; CHT701 , Lot Number 21FBO591 ; CHT701 , Lot Number 21JBW717 ; CHT701 , Lot Number 21VBA867 ; CHT701 , Lot Number 21KBN653 ; CHT701 , Lot Number 22CBO057 ; CHT701 , Lot Number 22EBG420 ; CHT701 , Lot Number 22JBM927 ; CHT701 , Lot Number 22JBT787 ; CHT701 , Lot Number 23GBR820 ; CHT701 , Lot Number 23JBK474 ; CHT701 , Lot Number 21CBO702 ; CHT701 , Lot Number 21FBD963 ; CHT705, Lot Number 2020012990; CIT6260, Lot Number 2021101590; CIT6325, Lot Number 2023120790; CIT6575A , Lot Number 22KBS245 ; CIT6575A , Lot Number 22LBL593 ; CIT6785A, Lot Number 2021072790; CIT6785A, Lot Number 2021111690; CIT6785A, Lot Number 2023102490; CVI2105, Lot Number 21JBM278 ; CVI2105, Lot Number 21KBS086 ; CVI2105, Lot Number 21BBH919 ; CVI2105, Lot Number 21CBI631 ; CVI2105, Lot Number 21CBI632 ; CVI2105, Lot Number 21DBA095 ; CVI2105, Lot Number 22FMD732 ; CVI2105, Lot Number 22HMD248 ; CVI2105, Lot Number 23EMI806 ; CVI2105, Lot Number 23FMA158 ; CVI2105, Lot Number 23FMH191 ; CVI2105,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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