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.
Recall
- Recall Number
- Z-2806-2020
- Event Number
- 86036
- Firm
- Argon Medical Devices, Inc
- FEI Number
- 1625425
- Product Code
- DRE
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- June 19, 2020
- Terminated
- April 12, 2023
- Address
- 1445 Flat Creek Rd, Athens, TX, 75751-5002
Description
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.
Sterile introducer sheath set manufactured under one lot with different expiration dates.
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.
US Nationwide distribution including in the state of MS.
1000 units