Recall Z-2427-2020 ยท KNW Instrument, Biopsy
Argon Medical Devices, Inc
BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal masses, etc.
| Date | Dec 2, 2019 |
| Status | Terminated |
| Reason | Incorrect product labeling. |
| Root cause | Labeling Change Control |
| Action | On December 2, 2019, the firm sent out a "NOTIFICATION OF RECALL" to customers via registered mail, informing customers of the wrong/incorrect, label on the device. The firm requested to their customers to complete the recall form and return it to the firm with the packaged, unused devices. Customers were instructed to inspect, quarantine and return any affected product remaining at their facility utilizing the instruction on the "Recall Response Form". Customers were also instructed to complete the response acknowledgement form included with the letter and return by fax, mail or email as soon |
| Quantity | 165 units in U.S. and 330 units Internationally |
| Distribution | Worldwide distribution - US Nationwide including in the states of TX, IL, FL, KS, MD, CA, WA, NY, WI, PA and the countries of United Arab Emirates (Dubai), Spain, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904987 | VIBRONICS AUTO CORE BIOPSY DEVICE (ACBD) Vibronics, Feb 11, 1991 |