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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74599

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 13, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AccessClosure, Inc., A Cardinal Health Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2329-2016
Recall number
Z-2329-2016
Initiated
July 13, 2016
Classification
Class II
Status
Terminated
Quantity
55 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.

Code information

Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016

Distribution pattern

US in the states of CA, and MS.