Z-2329-2016Class II

6F/7F MynxGrip Vascular Closure Device; Product Model MX6721

Name: Z-2329-2016 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721
Creator: AccessClosure, Inc., A Cardinal Health Company
Published: 2016-07-13
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2016-07-13 / Terminated / root cause: manufacturing process

FDA source

AccessClosure, Inc., A Cardinal Health Company began a recall of 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... on 2016-07-13. FDA classified it as Class II and gives the reason as "A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2329-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-13
Posted: 2016-08-03
Terminated: 2016-08-15
Recalling firm: Cordis US Corp.
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.
Product code: MGB Device, Hemostasis, Vascular
Reason for recall: A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cardinal Health sent an Urgent Medical Device letters dated July 15, 2016 to affected customers. The letters provided the reason for recall and the exact lot number and quantity shipped to each location. Customers were instructed to quarantined affected products and complete and return the Field Action response form indicating the number of devices that will be returned. Instructions for returning the devices are included with an RMA number and Fed Ex airbill. Questions should be directed to Customer Advocacy at 408-610-6570 between 9 am and 5 pm PST.
Quantity in commerce: 55 units
Distribution: US in the states of CA, and MS.
Product codes and lots: Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2329-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2329-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-03

Product code MGB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)