FDAFDA · Food and drugs·Recall number 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
Published January 17, 2024 · Recall initiated: November 8, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Peripheral Vascular Inc
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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