FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
- Recall number
- Z-1564-2023
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
- Status
- Open, Classified
- Initiated
- 2023-04-11
- Posted
- 2023-05-05
- Terminated
- not on file
- Reason
- Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
- Root cause
- Mixed-up of materials/components
- Action
- On 04/11/23 recall notices were distributed to customers who were asked to do the following: 1. Discontinue use and dispose of affected product. 2. Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. 3. If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution or replacement product. 4. Complete and return the Customer Response Form to BRDC31@bd.com In addition, distributors were asked to do the following: 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 field action notification. If you require further assistance please contact: North American Regional Complaint Center, Phone: 1-844-8BD- LIFE (1-844-823-5433), say "Recall" when prompted, M-F 8am - 5pm CT, or email: productcomplaints@bd.com
- Quantity
- 4,120
- Distribution
- US Nationwide Distribution: PR, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY . OUS: BE, CA, AU
- Lot, serial or model codes
- REF/UDI-DI/Lot (Expiration Date): 2010MSK/00801741097089/0001445946(11/28/2024), 2016MSK/00801741097096/1458844(02/28/2025)
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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