Cordis recalls MYNXGRIP 6F/7F vascular closure devices due to incorrect carton labels for some lots. Affected units may have wrong lot numbers, but individual device labels are correct.
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.
Cordis is recalling certain MYNXGRIP 6F/7F vascular closure devices because some carton boxes have incorrect lot numbers. This mix-up could lead to confusion about which devices are being used, but it does not pose a safety risk to patients or users.
The carton boxes for some lots of the device have incorrect lot numbers printed on them. This could cause confusion about which devices belong to which lot, but the individual device labels are correct and do not affect safety.
Healthcare professionals using the MYNXGRIP 6F/7F vascular closure devices for femoral access procedures. Patients are not at risk as the individual device labels are correct.
Check the carton box label for lot numbers: F2322903 (for MYNXGRIP 6F/7F) or F2322902 (for MYNXGRIP 5F). The individual device labels are correct and should not be confused.
Check the carton box for lot numbers: F2322903 indicates MYNXGRIP 6F/7F, while F2322902 indicates MYNXGRIP 5F.
No, the individual device labels are correct and this label mix-up does not pose a safety risk to patients.
No, the recall is only about label confusion, not safety. Devices can be used as normal.
Check the carton box label for lot numbers: F2322903 (for MYNXGRIP 6F/7F) or F2322902 (for MYNXGRIP 5F).
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-0675-2024 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-0675-2024 from Cordis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
