Recalls / —
—#182544
Product
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer 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.
- FDA product code
- DRE — Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K780126
- Affected lot / code info
- LOT 11295042
Why it was recalled
Sterile introducer sheath set manufactured under one lot with different expiration dates.
Root cause (FDA determination)
Employee error
Action the firm took
The recalling firm communicated to Medtronic the recommendation of a voluntary recall. The product is an OEM product manufactured specifically for Medtronic, and Argon does not have visibility to the end-use customers receiving these products. On 06/19/2020 the OEM customer was notified about the recall via telephone call and had requested to return all unused units.
Recalling firm
- Firm
- Argon Medical Devices, Inc
- Address
- 1445 Flat Creek Rd, Athens, Texas 75751-5002
Distribution
- Distribution pattern
- US Nationwide distribution including in the state of MS.
Timeline
- Recall initiated
- 2020-06-19
- Terminated
- 2023-04-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #182544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.