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U.S. Department of Health and Human Services

Class 2 Device Recall MynxGrip Vascular Closure Device

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  Class 2 Device Recall MynxGrip Vascular Closure Device see related information
Date Initiated by Firm July 13, 2016
Date Posted August 03, 2016
Recall Status1 Terminated 3 on August 15, 2016
Recall Number Z-2329-2016
Recall Event ID 74599
PMA Number P040044 
Product Classification Device, hemostasis, vascular - Product Code MGB
Product 6F/7F MynxGrip Vascular Closure Device;
Product Model MX6721,

Product Usage:
The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is comprised of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30-days.
Code Information Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016
Recalling Firm/
Manufacturer		 AccessClosure, Inc., A Cardinal Health Company
5452 Betsy Ross Dr
Santa Clara CA 95054-1101
For Additional Information Contact Donielle Baudin
408-610-6500
Manufacturer Reason
for Recall		 A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
FDA Determined
Cause 2		 Process control
Action Cardinal Health sent an Urgent Medical Device letters dated July 15, 2016 to affected customers. The letters provided the reason for recall and the exact lot number and quantity shipped to each location. Customers were instructed to quarantined affected products and complete and return the Field Action response form indicating the number of devices that will be returned. Instructions for returning the devices are included with an RMA number and Fed Ex airbill. Questions should be directed to Customer Advocacy at 408-610-6570 between 9 am and 5 pm PST.
Quantity in Commerce 55 units
Distribution US in the states of CA, and 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.
PMA Database PMAs with Product Code = MGB and Original Applicant = Cordis US Corporation
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