Merit Medical recalls Custom Sheath Introducer Kit REF K21-0: incorrect sheath size included may cause bleeding, clots, or blockages during medical procedures.
labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.
Merit Medical is recalling a specific Custom Sheath Introducer Kit because it includes the wrong sheath size and assembly. Using this kit could lead to bleeding, clots, or blockages in blood vessels during medical procedures.
The kit includes the wrong sheath size and assembly due to a labeling error. This mismatch can cause blood vessels to constrict, leading to bleeding, clots, or blockages during medical procedures.
Healthcare professionals using this kit for medical procedures are most at risk. Patients receiving procedures with this kit could experience bleeding or clotting issues.
Check for the catalog number K21-00031 and lot number H1583914 on the product packaging. The kit was sold with incorrect sheath sizes and assemblies.
Verify the sheath size and assembly matches the product label and catalog number K21-00031.
Reach out to Merit Medical Systems for assistance with the correct kit components.
No, the hazard is due to incorrect sheath size included in the kit, not normal use.
Check the kit components against the catalog number K21-00031 and contact Merit Medical Systems for help.
Only if the sheath size and assembly match the product label; otherwise, there is a risk of bleeding or clots.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1956-2020 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1956-2020 from Merit Medical Systems. 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.
