Z-0675-2024Class II

MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous...

Name: Z-0675-2024 MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous...
Creator: Cordis US Corp
Published: 2023-11-28
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2023-11-28 / Open, Classified / root cause: labeling and UDI

FDA source

Cordis US Corp began a recall of MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites on 2023-11-28. FDA classified it as Class II and gives the reason as "Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0675-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-28
Posted: 2024-01-05
Recalling firm: Cordis US Corp.
Product: MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Product code: MGB Device, Hemostasis, Vascular
Reason for recall: Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Cordis issued an Urgent MEDICAL DEVICE RECALL notice to its consignees on 11/28/2023 via via FEDEX. The notice explained the issue and requested the return of any affected product in inventory. For questions related to the recall and/or acknowledgement form that are not adequately addressed in the letter, please contact Cordis QA at: [email protected] or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.
Quantity in commerce: 70 units
Distribution: US: NC, WV, TN, MS, MI, OH, CA
Product codes and lots: UDI/DI 10862028000403, Lot numbers: F2322903

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0675-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0674-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05
Z-0675-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-05

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)