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
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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.
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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
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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.
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PMA Database |
PMAs with Product Code = MGB and Original Applicant = Cordis US Corporation
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