Recall Z-2806-2020 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Argon Medical Devices, Inc
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
| Date | Jun 19, 2020 |
| Status | Terminated |
| Reason | Sterile introducer sheath set manufactured under one lot with different expiration dates. |
| Root cause | Employee error |
| 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. |
| Quantity | 1000 units |
| Distribution | US Nationwide distribution including in the state of MS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780126 | DILATOR, VESSEL & INTRODUCER, SHEATH Argon Medical Corp., Mar 2, 1978 |