Class 2 Device Recall ClosureFast Micro Introducer Sheath Set

• Date Initiated by Firm: February 17, 2016
• Date Posted: March 01, 2016
• Recall Status: Terminated 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: 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