BioPince Biopsy Instrument (Argon Medical) – Packaging Breach (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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 may use this device 4) Complete and return the response form via email to Arbee.cummings@argonmedical.com