FDAFDA · Alimentos y medicamentos·N.º oficial Z-0643-2024
Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Kit 18G x 20CM; 1825MSK/ Mission Kit 18G x 25CM; 2010MSK/ Mission Kit 20G x 10CM; 2016MSK/ Mission Kit 20G x 16CM; 2020MSK/ Mission Kit 20G x 20CM
Publicado el 17 de enero de 2024 · Inicio del retiro: 8 de noviembre de 2023
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
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Bard Peripheral Vascular Inc
- Distribuidor
- Worldwide - US Nationwide distribution including in the states of PR, IL, MA, GA, KY, CA, TX, PA, IA, MN, NH, MD, FL, ID, IN, AL, VA, CO, WI, NY, NV, OK, OH, WA, MI, MS, AZ, HI, SD, NJ, NE, MT, NC, DC, CT, WY, UT, TN, LA, NM, SC, VT, MO, ME, AR, OR, KS, RI, AK, WV, DE, ND, PR, GU and the countries of CA, BE, AU, KR, SG, CN, TH, HK, VI, VN, AR, JP, CL, IN, TW, CO, MX, DO, BR, BD, MM, PK, NP, PA.
- Lote
- REF/UDI-DI/Lot (Expiration Date): 1410MSK/ 00801741142543/ 0001418630(05/28/24), 0001429851(07/28/24), 0001433778(08/28/24), 0001441794(10/28/24), 0001443076(10/28/24, 0001446454(11/28/24, 0001451131(01/28/25, 0001452840(01/28/25, 0001463142(03/28/25, 0001468867(04/28/25, 0001475757(06/28/25, 0001481508(07/28/25, 0001485193(08/28/25, 0001487094(08/28/25, 0001488512(08/28/25, 0001491080(09/28/25, 0001491583(09/28/25, 0001498859(11/28/25, 0001502349(12/28/25); 1416MSK/ 00801741142550/0001402196(01/28/24), 0001423061(06/28/24), 0001430525(07/28/24), 0001434059(08/28/24), 0001435619(09/28/24), 0001452376(01/28/25), 0001458437(02/28/25), 0001464693(03/28/25), 0001464694(03/28/25); 1610MSK/ 00801741142567/0001390419(10/28/23), 0001392740(10/28/23), 0001402197(01/28/24), 0001415815(04/28/24), 0001418632(05/28/24), 0001426735(06/28/24), 0001426839(07/28/24), 0001430408(07/28/24), 0001430528(07/28/24), 0001433779(08/28/24), 0001468480(04/28/25), 0001468479(04/28/25), 0001474221(05/28/25), 0001478981(06/28/25), 0001481036(07/28/25), 0001481035(07/28/25), 0001480804(07/28/25), 0001480805(07/28/25), 0001485185(08/28/25), 0001487093(08/28/25), 0001486540(08/28/25), 0001491078(09/28/25), 0001502344(12/28/25); 1616MSK/ 00801741142574/0001410073(02/28/24), 0001418633(05/28/24), 0001429719(07/28/24), 0001432764(08/28/24), 0001441990(10/28/24), 0001445629(11/28/24), 0001451613(01/28/25), 0001468728(04/28/25), 0001474220(05/28/25), 0001474506(05/28/25), 0001476311(06/28/25), 0001480541(07/28/25), 0001480542(07/28/25), 0001498110(11/28/25); 1810MSK/ 00801741097058/0001390415(10/28/23), 0001390414(10/28/23), 0001392714(10/28/23), 0001393862(10/28/23), 0001394226(10/28/23), 0001394535(10/28/23), 0001398597(12/28/23), 0001398596(12/28/23), 0001399830(12/28/23), 0001398961(12/28/23), 0001400410(12/28/23), 0001400409(12/28/23), 0001402163(01/28/24), 0001402164(01/28/24), 0001402165(01/28/24), 0001411232(03/28/24), 0001412043(03/28/24), 0001412042(03/28/24), 0001412044(03/28/24), 0001411871(03/28/24), 0001411233(03/28/24), 0001415831(04/28/24), 0001415832(04/28/24), 0001415833(04/28/24), 0001418634(05/28/24), 0001418637(05/28/24), 0001418638(05/28/24), 0001418639(05/28/24), 0001418635(05/28/24), 0001423157(06/28/24), 0001423153(06/28/24), 0001423889(06/28/24), 0001423818(06/28/24), 0001425382(06/28/24), 0001425996(06/28/24), 0001427153(07/28/24), 0001427154(07/28/24), 0001427151(07/28/24), 0001427971(07/28/24), 0001428062(07/28/24), 0001428063(07/28/24), 0001428595(07/28/24), 0001428594(07/28/24), 0001428593(07/28/24), 0001432766(08/28/24), 0001432765(08/28/24), 0001435553(09/28/24), 0001435552(09/28/24), 0001436593(09/28/24), 0001436594(09/28/24), 0001436596(09/28/24), 0001437223(09/28/24), 0001439097(10/28/24), 0001439098(10/28/24), 0001440545(10/28/24), 0001440550(10/28/24), 0001440546(10/28/24), 0001440547(10/28/24), 0001440548(10/28/24), 0001441274(10/28/24), 0001441333(10/28/24), 0001441334(10/28/24), 0001442964(10/28/24), 0001442322(10/28/24), 0001444346(11/28/24), 0001444344(11/28/24), 0001444348(11/28/24), 0001444345(11/28/24), 0001445638(11/28/24), 0001444347(11/28/24), 0001448511(12/28/24), 0001448510(12/28/24), 0001448509(12/28/24), 0001448508(12/28/24), 0001448746(12/28/24), 0001448745(12/28/24), 0001450208(12/28/24), 0001450000(12/28/24), 0001452266(01/28/25), 0001452380(01/28/25), 0001452267(01/28/25), 0001457033(02/28/25), 0001457034(02/28/25), 0001458731(02/28/25), 0001458730(02/28/25), 0001459349(02/28/25), 0001458728(02/28/25), 0001458729(02/28/25), 0001460530(03/28/25), 0001465424(04/28/25), 0001465423(04/28/25), 0001465703(04/28/25), 0001465704(04/28/25), 0001466004(04/28/25), 0001466003(04/28/25), 0001466075(04/28/25), 0001465493(04/28/25), 0001465883(04/28/25), 0001465491(04/28/25), 0001465492(04/28/25), 0001467088(04/28/25), 0001465882(04/28/25), 0001467181(04/28/25), 0001467180(04/28/25), 0001468726(04/28/25), 0001470276(05/28/25), 0001470007(05/28/25), 0001469995(05/28/25), 0001473075(05/28/25), 0001473604(05/28/25), 0001
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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