Merit Medical Systems recalls Custom Procedure Kit (K12T-10167) due to incorrect latex labeling. This may cause confusion about whether the kit contains latex. Affected units were sold with a label claiming 'Latex Free' but contain latex.
Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
Merit Medical Systems is recalling a Custom Procedure Kit (Vein Kit) because it has incorrect latex labeling. The kit claims to be 'Latex Free' but actually contains latex, which could cause allergic reactions in sensitive users. This is a labeling error, not a safety hazard.
The kit was labeled as 'Latex Free' but contains latex. This could lead to allergic reactions in individuals sensitive to latex, especially during medical procedures where the kit is used. The error is a labeling mistake, not a physical defect.
Healthcare professionals using the kit for procedures may be affected. Those with latex allergies are at higher risk due to potential exposure.
Check for the product code K12T-10167 on the kit. The kit was sold with a label claiming 'Latex Free' but contains latex. It was manufactured for single-use procedures only.
Look for the label that says 'Latex Free' on the kit. If it says this but contains latex, it is affected.
The kit may contain latex despite labeling as 'Latex Free', so it is not safe for those with latex allergies. However, it is not a safety hazard for general use.
The kit has product code K12T-10167 and was sold with a label claiming 'Latex Free' but contains latex.
The recall does not specify a return or disposal action, so no action is required beyond checking the labeling.
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-0027-2020 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-0027-2020 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.
