Merit Medical recalls Custom Procedure Kit (K12T-03688) due to incorrect latex labeling. This may cause confusion about whether the kit is latex-free, but does not pose a safety risk.
Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
Merit Medical is recalling a specific custom procedure kit because it has incorrect latex labeling. This means the kit might not be properly labeled as latex-free, but it does not pose a safety risk to users.
The kit was labeled as latex-free but contains latex. This could cause confusion for healthcare providers about whether the kit is safe for latex-sensitive patients. However, the labeling error does not create a safety risk during normal use.
Healthcare providers who purchased the Custom Procedure Kit (K12:03688) with lot numbers T1401193 or T1419935 are affected. Patients using this kit are at minimal risk since the issue is labeling-related and not a safety hazard.
Check for the product code K12T-03688 with lot numbers T1401193 or T1419935. The kit is sold as a single-use, sterile, latex-free product for medical procedures.
Check the product code and lot numbers on the kit to confirm if it is affected.
No, this recall is for labeling accuracy only and does not pose a safety risk.
The official recall does not require stopping use or returning the kit. Verify the product details to confirm if it is affected.
Check for product code K12T-03688 with lot numbers T1401193 or T1419935.
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-0026-2020 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-0026-2020 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.
