Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 10, 2016
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 o
A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
AccessClosure, Inc., A Cardinal Health Company recalled 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/… - a moderate-severity action.
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/… was recalled by AccessClosure, Inc., A Cardinal Health Company in August 10, 2016. Reason: A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging conf…. Check the official notice for the remedy. Verify recall #Z-2329-2016 with the FDA Devices before acting.
The recall
AccessClosure, Inc., A Cardinal Health Company issued this moderate-severity FDA Devices recall-A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging conf….
- Moderate
- severity level
- 55 units
- affected scope
- Class II
- classification
- August 10, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2329-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2329-2016) was formally reported on August 10, 2016, with the manufacturer initiating the action on July 13, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. AccessClosure, Inc., A Cardinal Health Company is listed as the recalling firm, operating out of Santa Clara, CA. Federal records list the affected scope as 55 units.
The documented reason for this recall is: A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations. Distribution data in the federal record shows the product reached: US in the states of CA, and MS.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
55 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2329-2016 |
| Date reported | August 10, 2016 |
| Date initiated | July 13, 2016 |
| Recalling firm | AccessClosure, Inc., A Cardinal Health Company |
| Firm location | Santa Clara, CA |
| Affected scope | 55 units |
| Distribution | US in the states of CA, and MS. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2329-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by AccessClosure, Inc., A Cardinal Health Company. Units affected: 55 units.
Why was this product recalled? ▼
A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2016. Severity: Moderate. Recall number: Z-2329-2016.
Where was the recalled product distributed? ▼
Distribution: US in the states of CA, and MS..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2329-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 10, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.