AccessClosure, Inc., A Cardinal Health Company: Medical Device Recall in 2016 - (Recall #: Z-2329-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 13, 2016

Date Posted: August 10, 2016

Recall Number: Z-2329-2016

Event ID: 74599

Reason for Recall:

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

Status: Terminated

Product Quantity: 55 units

Code Information:

Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016

Distribution Pattern:

US in the states of CA, and MS.

Voluntary or Mandated:

Voluntary: Firm initiated