—#198974

Product

Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM

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): 2010MSK/00801741097089/0001445946(11/28/2024), 2016MSK/00801741097096/1458844(02/28/2025)

Why it was recalled

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 (FDA determination)

Mixed-up of materials/components

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2023-04-11
Posted by FDA: 2023-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198974. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.