6F/7F MynxGrip Vascular Closure Device — Class II medical device recall Z-2329-2016
Terminated recall by AccessClosure, Inc., A Cardinal Health Company, reported 2016-08-10, distributed in CA, MS. A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging confi
| Recall number | Z-2329-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AccessClosure, Inc., A Cardinal Health Company, Santa Clara, CA, United States |
| Recall initiated | 2016-07-13 |
| Classified | 2016-08-03 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2016-08-15 |
| Distributed | CA, MS |
| Quantity | 55 units |
| Lot numbers | F1534302, F1609702 |
| Model numbers | MX6721 |
| Expiration dates | 2016-12-31, 2018-04-20 |
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 for recall
A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2329-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.