FDA Device recall Z-2329-2016
6F/7F MynxGrip Vascular Closure Device
- FDA Device
- Class II
- terminated
- Published 2016-08-10
On 2016-08-10 the FDA classified a Class II recall of 6F/7F MynxGrip Vascular Closure Device by Accessclosure A Cardinal Health, citing A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2329-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-13 |
| Published | 2016-08-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Accessclosure A Cardinal Health |
| Distribution | CA, MS |
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.
Identifiers
| code_info | Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2329-2016%22
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