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.
This recall has been terminated (originally issued June 19, 2020).
- Company
- Argon Medical Devices, Inc
- Recall Initiated
- June 19, 2020
- Terminated
- April 12, 2023
- Recall Number
- Z-2806-2020
- Quantity
- 1000 units
- Firm Location
- Athens, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Sterile introducer sheath set manufactured under one lot with different expiration dates.
Distribution
US Nationwide distribution including in the state of MS.
Lot / Code Info
LOT 11295042
Root Cause
Employee error
Action Taken
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.
More recalls by Argon Medical Devices, Inc
Option"ELITE Vena Cava Filter System REF 352506070E
UDI-DI code: 00886333217151
The Option"ELITE F...
Nov 24, 2025
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-158...
Sep 20, 2024
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Aug 16, 2024