Recall Z-0643-2024 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
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
| Date | Jan 5, 2024 (initiated Nov 8, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On 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 d |
| Quantity | 1,243,937 |
| Distribution | 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 o |
| 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 |