MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Summary
The FDA issued a Class II for MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral by Cordis US Corp. Reason: 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.
Details
Source
Device Recall
External ID
Z-0675-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
Product Description
MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Lot/Code Info: UDI/DI 10862028000403, Lot numbers: F2322903
Quantity Affected: 70 units
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.
Distribution
US: NC, WV, TN, MS, MI, OH, CA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-28
Company
Miami Lakes, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cordis US Corp has 26 FDA actions in our database, including 22 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cordis US Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cordis US Corp have FDA actions?
Cordis US Corp has 26 FDA actions in our database, including 22 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0675-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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