Recall Z-1564-2023 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
| Date | May 5, 2023 (initiated Apr 11, 2023) |
| Status | Open, Classified |
| 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 dist |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171953 | Bard Mission Disposable Core Biopsy Instrument Bard Peripheral Vascular, Inc., Sep 14, 2017 |