Recall Z-1260-2023 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
| Date | Mar 16, 2023 (initiated Feb 28, 2023) |
| Status | Open, Classified |
| Reason | The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility. |
| Root cause | Mixed-up of materials/components |
| Action | On 2/28/23, "URGENT MEDICAL DEVICE RECALL" notices were mailed and emailed to customers and distributors who were told to take the following actions: 1) Discontinue use of and 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 field action. 3) If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution. 4) Complete and return the attached Customer Res |
| Quantity | 38,635 |
| Distribution | Worldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO, PA, TX, NC, CA, ME, MO, NV, MI, IL, NY, VA, AZ, NH, LA, WI, KY, MA, WA, CT, SD, OK, DC, IA, AR, GA, NE, NM, IN, NJ, MN, PR, AL, AK, SC, KS, OR, ID, VT, MT, WV, ND, TN, MS, HI, WY, RI and OUS countries of: Canada, Korea, Thai |
| 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 |