Z-2329-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 10, 2016
- Initiation Date
- July 13, 2016
- Termination Date
- August 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 units
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.
Reason for Recall
A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
Distribution Pattern
US in the states of CA, and MS.
Code Information
Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016