Z-0675-2024 Class II Ongoing
FDA device recall Z-0675-2024 was initiated by Cordis US Corp on November 28, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 70 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2024
- Initiation Date
- November 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units
Product Description
MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
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 Pattern
US: NC, WV, TN, MS, MI, OH, CA
Code Information
UDI/DI 10862028000403, Lot numbers: F2322903