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U.S. Department of Health and Human Services

Class 2 Device Recall ClosureFast Micro Introducer Sheath Set

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 Class 2 Device Recall ClosureFast Micro Introducer Sheath Setsee related information
Date Initiated by FirmJune 19, 2020
Create DateAugust 14, 2020
Recall Status1 Terminated 3 on April 12, 2023
Recall NumberZ-2806-2020
Recall Event ID 86036
510(K)NumberK780126 
Product Classification Dilator, vessel, for percutaneous catheterization - Product Code DRE
ProductClosureFast 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
FEI Number 1625425
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information ContactMs. 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
ActionThe 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 Commerce1000 units
DistributionUS Nationwide distribution including in the state of MS.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DRE
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