AccessClosure, Inc., A Cardinal Health Company recalls 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device…

Recall date

July 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2329-2016

FDA classification

Class II

Brand / firm

AccessClosure, Inc., A Cardinal Health Company

Sold / distributed

US in the states of CA, and MS.

Why it was recalled

A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.