Bard Peripheral Vascular Inc: 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

Recall number

Z-0643-2024

Recalling firm

Bard Peripheral Vascular Inc

Product

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

Status

Open, Classified

Initiated

2023-11-08

Posted

2024-01-05

Terminated

not on file

Reason

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.

Root cause

Process control

Action

On 11/8/23, recall notices were distributed to customers and distributors who were asked to do the following: 1) Discontinue use of affected product, and immediately dispose of all affected product remaining in your possession in accordance with your local facility's process. 2) Share this notification with all users within your facility network of the product to ensure they are also aware of this recall. If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution. - Distributors were asked to Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this expanded field action notification. 3) Complete and return the attached Customer Response Form via email to BDRC3@bd.com Customers requiring additional assistance can contact the firm's North American Regional Complaint Center by phone: 1-844-823-5433, say "recall" when prompted M-F 8am - 5pm CT, or via email: productcomplaints@bd.com

Quantity

1,243,937

Distribution

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, serial or model codes

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0001448748(12/28/24)0001449432(12/28/24), 0001449433(12/28/24), 0001456597(02/28/25), 0001456153(02/28/25), 0001456573(02/28/25), 0001456936(02/28/25), 0001456596(02/28/25),0001459554(02/28/25),0001461729(03/28/25), 0001461728(03/28/25), 0001462125(03/28/25), 0001475009(05/28/25), 0001475008(05/28/25), 0001478968(06/28/25), 0001478963(06/28/25), 0001479643(06/28/25), 0001479644(06/28/25), 0001482928(07/28/25), 0001482931(07/28/25), 0001482930(07/28/25), 0001482932(07/28/25), 0001482929(07/28/25), 0001482934(07/28/25), 0001488082(08/28/25), 0001487710(08/28/25), 0001487711(08/28/25), 0001487602(08/28/25), 0001488510(08/28/25), 0001488081(08/28/25), 0001490705(09/28/25), 0001490708(09/28/25), 0001490706(09/28/25), 0001498139(11/28/25), 0001498140(11/28/25), 0001503043(12/28/25), 0001503044(12/28/25), 0001504002(12/28/25), 0001503958(12/28/25), 0001445946(11/28/24); 2016MSK/ 00801741097096/0001390417(10/28/23), 0001390418(10/28/23), 0001392738(10/28/23), 0001394806(11/28/23), 0001395410(11/28/23), 0001398980(12/28/23), 0001398979(12/28/23), 0001401523(12/28/23), 0001401520(12/28/23), 0001402087(01/28/24), 0001402086(01/28/24), 0001415824(04/28/24), 0001415826(04/28/24), 0001418627(05/28/24), 0001418628(05/28/24), 0001423816(06/28/24), 0001423815(06/28/24), 0001428803(07/28/24), 0001428592(07/28/24), 0001429954(07/28/24), 0001430089(07/28/24), 0001430339(07/28/24), 0001432740(08/28/24), 0001432739(08/28/24), 0001434756(08/28/24), 0001437864(09/28/24), 0001441795(10/28/24), 0001441796(10/28/24), 0001442314(10/28/24), 0001442315(10/28/24), 0001442313(10/28/24), 0001442312(10/28/24), 0001445803(11/28/24), 0001445944(11/28/24), 0001445802(11/28/24), 0001445801(11/28/24), 0001448753(12/28/24), 0001448752(12/28/24),0001450642(12/28/24), 0001450646(12/28/24), 0001450644(12/28/24), 0001453528(01/28/25), 0001453530(01/28/25), 0001453529(01/28/25), 0001454098(01/28/25), 0001456155(02/28/25), 0001456154(02/28/25), 0001457603(02/28/25), 0001457602(02/28/25), 0001458843(02/28/25), 0001469201(04/28/25), 0001469202(04/28/25), 0001469200(04/28/25), 0001469577(04/28/25), 0001475585(05/28/25), 0001475411(05/28/25), 0001475410(05/28/25), 0001475412(05/28/25), 0001476363(06/28/25), 0001476364(06/28/25), 0001478962(06/28/25), 0001478961(06/28/25), 0001480801(07/28/25), 0001483581(07/28/25), 0001483582(07/28/25), 0001486538(08/28/25), 0001487713(08/28/25), 0001486539(08/28/25), 0001489271(08/28/25), 0001489612(08/28/25), 0001487714(08/28/25), 0001492480(09/28/25), 0001492475(09/28/25), 0001492477(09/28/25), 0001492478(09/28/25), 0001492479(09/28/25), 0001492476(09/28/25), 0001495451(10/28/25), 0001497095(10/28/25), 0001497094(10/28/25), 0001497674(10/28/25), 0001497354(10/28/25), 0001498772(11/28/25), 0001499753(11/28/25), 0001499751(11/28/25), 0001499752(11/28/25), 0001500387(11/28/25), 0001503045(12/28/25), 0001503830(12/28/25), 0001503828(12/28/25), 0001503046(12/28/25), 0001503829(12/28/25), 0001458844(02/28/25); 2020MSK/ 00801741097102/0001412035(03/28/24), 0001414700(04/28/24), 0001415128(04/28/24), 0001422837(06/28/24), 0001425299(06/28/24), 0001425389(06/28/24), 0001435087(09/28/24), 0001439257(10/28/24), 0001443304(11/28/24), 0001451614(01/28/25), 0001463280(03/28/25), 0001464594(03/28/25), 0001469727(04/28/25), 0001469431(04/28/25), 0001469767(04/28/25), 0001469768(04/28/25), 0001471378(05/28/25), 0001487723(08/28/25), 0001491546(09/28/25), 0001492487(09/28/25), 0001494059(09/28/25), 0001499269(11/28/25), 0001504259(12/28/25)

510(k) numbers

["K171953"]

PMA numbers

not on file

Product code

KNW

Firm FEI

2020394

Firm city

Tempe

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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