FDA recall Z-2806-2020

Argon Medical Devices, Inc · Class II · device

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.

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.

Key facts

Status
Terminated
Initiation date
2020-06-19
Report date
2020-08-26
Termination date
2023-04-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2806-2020