BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 3

FDA device recall Z-3192-2024 · posted 2024-09-20 · Open, Classified

Recall details

Recalling firm

Argon Medical Devices, Inc

Reason for recall

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.

Action taken

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

Root cause

Packaging change control

Status

Open, Classified

Product code

KNW

Quantity affected

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

Date initiated

2024-07-02

Date posted

2024-09-20

Location

Athens, TX

Related 510(k) clearances