FDA Medical Device Recalls (openFDA)
Cordis US Corp: MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
- Recall number
- Z-0675-2024
- 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
- Status
- Open, Classified
- Initiated
- 2023-11-28
- Posted
- 2024-01-05
- Terminated
- not on file
- 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 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
- 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: 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.
- Quantity
- 70 units
- Distribution
- US: NC, WV, TN, MS, MI, OH, CA
- Lot, serial or model codes
- UDI/DI 10862028000403, Lot numbers: F2322903
- 510(k) numbers
- not on file
- PMA numbers
- ["P040044"]
- Product code
- MGB
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28