Date Initiated by Firm |
February 17, 2016 |
Date Posted |
March 01, 2016 |
Recall Status1 |
Terminated 3 on March 08, 2017 |
Recall Number |
Z-1029-2016 |
Recall Event ID |
73376 |
510(K)Number |
K780126
|
Product Classification |
Dilator, vessel, for percutaneous catheterization - Product Code DRE
|
Product |
ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. |
Code Information |
Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11) |
Recalling Firm/ Manufacturer |
Argon Medical Devices, Inc 1445 Flat Creek Rd Athens TX 75751-5002
|
For Additional Information Contact |
Rebecca Ellis 972-403-0749
|
Manufacturer Reason for Recall |
The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.
|
FDA Determined Cause 2 |
Process control |
Action |
On February 17, a letter was sent to Medtronic notifying them of a voluntary recall. |
Quantity in Commerce |
2000 units |
Distribution |
Distributed in IL. |
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.
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