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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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