Z-2806-2020 Class II Terminated
FDA device recall Z-2806-2020 was initiated by Argon Medical Devices, Inc on June 19, 2020 and is designated Class II. Reason for recall: Sterile introducer sheath set manufactured under one lot with different expiration dates. The recall status is terminated (terminated April 12, 2023). Affected quantity: 1000 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 26, 2020
- Initiation Date
- June 19, 2020
- Termination Date
- April 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1000 units
Product 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.
Reason for Recall
Sterile introducer sheath set manufactured under one lot with different expiration dates.
Distribution Pattern
US Nationwide distribution including in the state of MS.
Code Information
LOT 11295042