Cordis recalls MYNXGRIP 5F vascular closure devices due to incorrect lot numbers on carton boxes. This mix-up may cause confusion but does not pose a safety risk to users.
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 MYNXGRIP 5F vascular closure devices because some carton boxes have incorrect lot numbers. This labeling error could lead to confusion about which devices are being used, but it does not create a safety hazard.
The carton boxes for some shipments of MYNXGRIP 5F devices have incorrect lot numbers printed on them. This mix-up could cause confusion about which devices belong to which lot, but it does not affect the safety of the devices themselves.
Medical professionals using Cordis MYNXGRIP 5F devices for vascular access procedures may be affected if they receive the incorrectly labeled carton boxes. Patients are not at risk as the devices themselves are safe.
Check the carton box for lot numbers F2322902 or F2322903. The product is labeled as MYNXGRIP 5F (MX5021) or MYNXGRIP 6/7F (MX6721) on the individual devices. The recall applies to devices sold with these specific lot numbers.
Verify the lot number on the carton box matches the actual lot number for the device (F2322902 for MYNXGRIP 5F or F2322903 for MYNXGRIP 6/7F).
Cordis became aware that some carton boxes have incorrect lot numbers printed on them, which could cause confusion about which devices belong to which lot.
No, this labeling error does not pose a safety risk to users. The devices themselves are safe and the primary label on individual devices is correct.
Check the carton box for the lot number. If it matches F2322902 or F2322903, you may keep using the device as the labeling error does not affect safety.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-0674-2024 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-0674-2024 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.
