Recall Z-3192-2024 ยท KNW Instrument, Biopsy
Argon Medical Devices, Inc
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 7631142
| Date | Sep 20, 2024 (initiated Jul 2, 2024) |
| Status | Open, Classified |
| Reason | Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis. |
| Root cause | Packaging change control |
| Action | On 7/2/24, recall notices were mailed and emailed to Physician, Clinician, or Hospital Administrators who were asked to do the following: 1) Discontinue use of affected devices. 2) Segregate, quarantine, and return affected devices to the recalling firm. 3) Share this recall notice with the following parties to ensure your consignees receive a copy of this notice and the associated response form: a. Anyone who needs to be aware within your organization b. Any organization where the potentially affected products have been transferred or further distributed c. Anyone within your organization who |
| Quantity | 95,430 |
| Distribution | Worldwide - US Nationwide distribution including in the states of AZ, FL, OH, NY, MO, CO, IL, NC, CA, AK, PA, MN, ND, TX, SC, AR, WI, OK, TN, KS, UT, NJ, VA, MA, KY, IN, AL, DE, MT, NE, WV, NV, HI, OR, WA, NH, LA, CT, MI, GA, MD, ID, MS, IA, RI, NM, VT and the countries of ITA, TUN, ROU, LTU, BEL, |
| FDA record | Open on fda.gov |