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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93578

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 08, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Bard Peripheral Vascular Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0643-2024
Recall number
Z-0643-2024
Initiated
November 08, 2023
Classification
Class II
Status
Ongoing
Quantity
1,243,937

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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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)

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.