Reported Aug 26, 2020 · Terminated
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage:…
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?
ClosureFast Micro Introducer Sheath SetREF MIS-7F117Fr/Ch (2.3mm)x11 cm. STERILE|EO
- Rx ONLY - Product UsageIntroducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices
- Lot codes and dates
- LOT 11295042
- Amount recalled
- 1000 units
Where it was sold
- Nationwide
- MS
Why it was recalled
Sterile introducer sheath set manufactured under one lot with different expiration dates.
This product could cause temporary or reversible health problems — stop using it.
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