Recall Z-0674-2024
Cordis US Corp · initiated November 28, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Codes / lots: UDI/DI 10862028000403, Lot numbers: F2322902
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.
FDA-determined cause: Labeling Change Control
Action taken
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: GMB-CordisFieldAction@cordis.com or call Cordis Customer Support 1-800-327-7714 Option 2, Monday through Friday from 8:00 AM to 8:00 PM EDT.
Details
- Recall number
- Z-0674-2024
- Initiated
- November 28, 2023
- Posted by FDA
- January 5, 2024
- Product code
- MGB – Device, Hemostasis, Vascular
- Quantity
- 50 units
- Distribution
- US: NC, WV, TN, MS, MI, OH, CA
- Recalling firm
- Cordis US Corp, Miami Lakes, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0675-2024 Class II | MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial…Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two… | 11/28/2023Open, Classified |