Reported Oct 2, 2024 · Ongoing
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02,…
Argon Medical Devices, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Argon Medical Devices, Inc · 1445 Flat Creek Rd · Athens, TX · 75751-5002
Is this the product you have?
- BioPince
- Ultra Full Core Biopsy InstrumentREF:
- REF
360-1080-01360-1080-02360-1080-03360-1580-01360-1580-02360-1580-03360-2080-01360-2080-02360-2080-03370-1080-01370-1080-02370-1080-03370-1580-01370-1580-02370-1580-03Tru-Core II Biopsy Instrument
- REF
763114100x763116100X763116160X763118100X763118200X763120100X763120160X763418200X763418250X763114200X
- Lot codes and dates
25 of 25 products · 86 lot codes
Recalled lot codes, grouped by product number UDI-DI Unit UDI-DI Lot (Expiration Date) Lot codes and dates 360-1080-0120886333004373008863330043791156343622-Mar-20271156801016-Apr-2027115687901-May-2027115695527-May-20271157256020-May-2027
360-1080-0220886333224009008863332240051156367822-Mar-271156247505-Mar-271156247614-Mar-271156693208-Apr-271156713911-Apr-271156836116-Apr-271156901323-Apr-271156984429-Apr-271157109402-May-271157204408-May-271157288626-May-27
360-1080-0320886333224016008863332240121156984522-Apr-271156247704-Mar-271156486126-Mar-271156788812-Apr-271156855418-Apr-271157007504-May-27
360-1580-0120886333004359008863330043551156343821-Mar-20271156343919-Mar-2027
360-1580-0220886333224023008863332240291156247814-Mar-271156344018-Mar-271156368220-Mar-271156523803-Apr-271156688209-Apr-271157013201-May-271157081409-May-271157333920-May-27
360-1580-0320886333224030008863332240361157028802-May-271156344220-Mar-271156617303-Apr-271156688310-Apr-271156815316-Apr-271157081308-May-27
360-2080-0120886333004342008863330043481156356426-Mar-2027115660368-Apr-20271156799216-Apr-2027115701421-May-27115708638-May-27
360-2080-0220886333224047008863332240431156296407-Mar-271156392215-Mar-271156418922-Mar-27
360-2080-0320886333224054008863332240501156344315-Mar-271156693611-Apr-271156788922-Apr-2027
370-1080-0120886333004380008863330043861156479526-Mar-27
- Amount recalled
- 95,430
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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