Merit Medical recalls ChloraPrep With Tint patient preop solution due to nonsterile bulk product shipped to customers. This may pose infection risks during surgery preparation.
A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
Merit Medical is recalling ChloraPrep With Tint patient preoperative skin preparation solution because a nonsterile bulk product was accidentally shipped to customers. This could lead to infection risks during surgery preparation if used without proper sterilization.
The product was shipped as a nonsterile bulk item instead of the intended sterile product. This means it may not be safe for surgical skin preparation, potentially increasing infection risk during procedures.
Healthcare professionals using this product for patient skin preparation before surgery. Patients undergoing surgery are at risk if the nonsterile product is used without proper sterilization.
Check for the product name 'ChloraPrep With Tint', 10.5 ml size, Hi-Lite Orange color, and NDC 054365-400-12. The Merit lot number J559821 was associated with this recall.
Verify the product name, size, color, and NDC number to confirm if it matches the recalled items.
The recall indicates a nonsterile bulk product was shipped, so it may not be safe for surgical skin preparation without proper sterilization.
The recall does not specify a remedy, so check the product details to confirm if it matches the recalled items.
The recall does not mention serious injury risks, but improper use could lead to infection during surgery.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1702-2020 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1702-2020 from Merit Medical. 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.