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 Recall Z-2806-2020 · Posted None
Advertisement
Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeDRE
Date Initiated2020-06-19
Date Terminated2023-04-12
Product Quantity1000 units
Reason for Recall
Sterile introducer sheath set manufactured under one lot with different expiration dates.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
US Nationwide distribution including in the state of MS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement