Date Initiated by Firm |
June 19, 2020 |
Create Date |
August 14, 2020 |
Recall Status1 |
Terminated 3 on April 12, 2023 |
Recall Number |
Z-2806-2020 |
Recall Event ID |
86036 |
510(K)Number |
K780126
|
Product Classification |
Dilator, vessel, for percutaneous catheterization - Product Code DRE
|
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. |
Code Information |
LOT 11295042 |
Recalling Firm/ Manufacturer |
Argon Medical Devices, Inc 1445 Flat Creek Rd Athens TX 75751-5002
|
For Additional Information Contact |
Ms. Rebecca Ellis 903-675-9321
|
Manufacturer Reason for Recall |
Sterile introducer sheath set manufactured under one lot with different expiration dates.
|
FDA Determined Cause 2 |
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 in Commerce |
1000 units |
Distribution |
US Nationwide distribution including in the state of MS. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DRE and Original Applicant = ARGON MEDICAL CORP.
|