—#204901

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

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K171953
Affected lot / code info: 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), 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0001490742(09/28/25), 0001491039(09/28/25), 0001491021(09/28/25), 0001490741(09/28/25), 0001491022(09/28/25), 0001492549(09/28/25), 0001494131(10/28/25), 0001494132(10/28/25), 0001494195(10/28/25), 0001494843(10/28/25), 0001494841(10/28/25), 0001494844(10/28/25), 0001494842(10/28/25), 0001497923(10/28/25), 0001497741(10/28/25), 0001497740(10/28/25), 0001497925(10/28/25), 0001497739(10/28/25), 0001497924(11/28/25), 0001499062(11/28/25), 0001501269(12/28/25), 0001501273(12/28/25), 0001501270(12/28/25), 0001501272(12/28/25), 0001501263(12/28/25), 0001501267(12/28/25), 0001501271(12/28/25), 0001501264(12/28/25), 0001501268(12/28/25), 0001501265(12/28/25), 0001501266(12/28/25), 0001503385(12/28/25), 0001503382(12/28/25), 0001503384(12/28/25); 1816MSK/00801741097065/ 0001390396(10/28/23), 0001390397(10/28/23), 0001390398(10/28/23), 0001392710(10/28/23), 0001393863(10/28/23), 0001394534(10/28/23), 0001396998(11/28/23), 0001396999(11/28/23), 0001398599(12/28/23), 0001398919(12/28/23), 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0001456856(02/28/25); 1820MSK/ 00801741097072/0001390395(10/28/23), 0001393302(10/28/23), 0001395412(11/28/23), 0001399924(12/28/23), 0001398970(12/28/23), 0001402194(01/28/24), 0001412041(03/28/24), 0001412040(03/28/24), 0001414697(04/28/24), 0001414698(04/28/24), 0001415131(04/28/24), 0001415130(04/28/24), 0001418624(05/28/24), 0001422573(05/28/24), 0001422798(06/28/24), 0001424731(06/28/24), 0001435536(09/28/24), 0001435620(09/28/24), 0001439254(10/28/24), 0001439255(10/28/24), 0001439256(10/28/24), 0001443406(11/28/24), 0001443409(11/28/24), 0001449979(12/28/24), 0001458050(02/28/25), 0001458051(02/28/25), 0001461273(03/28/25), 0001464301(03/28/25), 0001464468(03/28/25), 0001465731(04/28/25), 0001476033(06/28/25), 0001476034(06/28/25), 0001476035(06/28/25), 0001477256(06/28/25), 0001480266(07/28/25), 0001480368(07/28/25), 0001480369(07/28/25), 0001487716(08/28/25), 0001488502(08/28/25), 0001487718(08/28/25), 0001487719(08/28/25), 0001489904(09/28/25), 0001489890(09/28/25), 0001489891(09/28/25), 0001493060(09/28/25), 0001490111(09/28/25), 0001496111(10/28/25), 0001496110(10/28/25), 0001498327(11/28/25), 0001498326(11/28/25), 0001500878(11/28/25), 0001502903(12/28/25), 0001504427(12/28/25); 1825MSK/ 00801741142581/0001440070(10/28/24), 0001443305(11/28/24), 0001455151(01/28/25), 0001480267(07/28/25), 0001498155(11/28/25), 0001502905(12/28/25); 2010MSK/00801741097089/ 0001390416(10/28/23), 0001392742(10/28/23), 0001395411(11/28/23), 0001398976(12/28/23), 0001402093(01/28/24), 0001414353(03/28/24), 0001414355(03/28/24), 0001412036(03/28/24), 0001414683(04/28/24), 0001415823(04/28/24), 0001415822(04/28/24), 0001418626(05/28/24), 0001420606(05/28/24), 0001423813(06/28/24), 0001427149(07/28/24), 0001430092(07/28/24), 0001430336(07/28/24), 0001430524(07/28/24), 0001432741(08/28/24), 0001437858(09/28/24), 0001442202(10/28/24), 0001445947(11/28/24), 0001445948(11/28/24), 0001445945(11/28/24), 0001448749(12/28/24), 0001448750(12/28/24), 0001448747(12/28/24), 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Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-11-08
Posted by FDA: 2024-01-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204901. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.