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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Mission Disposable Core Biopsy Instrument Kit

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 Class 2 Device Recall Bard Mission Disposable Core Biopsy Instrument Kitsee related information
Date Initiated by FirmNovember 08, 2023
Date PostedJanuary 05, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0643-2024
Recall Event ID 93578
510(K)NumberK171953 
Product Classification Instrument, biopsy - Product Code KNW
ProductBard 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
Code Information 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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Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
For Additional Information Contact
480-303-2602
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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 in Commerce1,243,937
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KNW
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