Recall Z-2329-2016— AccessClosure, Inc., A Cardinal Health Company

Class II FDA medical device recall by AccessClosure, Inc., A Cardinal Health Company, initiated 2016-07-13, terminated 2016-08-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations..

Recalling firm

AccessClosure, Inc., A Cardinal Health Company

Classification

Class II

Status

Terminated

Initiated

2016-07-13

Terminated

2016-08-15

Firm location

Santa Clara, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.