Reported Aug 10, 2016 · Terminated
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device…
AccessClosure, Inc., A Cardinal Health Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AccessClosure, Inc., A Cardinal Health Company · 5452 Betsy Ross Dr · Santa Clara, CA · 95054-1101
Is this the product you have?
6F/7F MynxGrip Vascular Closure DeviceProduct Model MX6721
- Product UsageThe 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
- Lot codes and dates
- Lot No
F1609702Expiry 4/20/2018Lot No. F1534302Expiry 12/31/2016
- Lot No
- Amount recalled
- 55 units
Where it was sold
Why it was recalled
A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
This product could cause temporary or reversible health problems — stop using it.
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