Reported Oct 12, 2016 · Terminated
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a…
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?
- MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
- Lot codes and dates
111496621115144711151617and 11149822
- Amount recalled
- 200 units
Where it was sold
Why it was recalled
The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath
This product could cause temporary or reversible health problems — stop using it.
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