Recall Z-1289-2021 ยท KNW Instrument, Biopsy
Bard Peripheral Vascular Inc
BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents
| Date | Jan 14, 2021 |
| Status | Terminated |
| Reason | Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use. |
| Root cause | Process control |
| Action | On 02/11/2021, the firm sent an "UGENT MEDICAL DEVICE RECALL" Notification Letter via FedEx or email to customers/distributors informing them that the Recalling Firm has received reports that the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use and may results in (1) prolongation of the biopsy procedures as the user obtains a replacement device, (2) undershooting the lesion unsuspectedly, compromising the sample quality and potentially leading to a misdiagnosis (3) or if the penetration is o |
| Quantity | Total 131,876 kits (102,210 kits U.S. and 29,666 kits O.U.S.) |
| Distribution | U.S.: 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, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY O.U.S.: Australia, Belgium, Canada, Europe, India, and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT Bard Peripheral Vascular, Inc., Feb 21, 2014 |