Merit Medical recalls Prelude Guide Sheath Roadster (PG6F45S018) due to potential inclusion of incorrect dilator size in sterile medical devices. Affected units may cause complications during procedures if used without proper verification.
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Merit Medical is recalling a specific type of medical sheath because some units might contain a larger dilator than labeled. This could lead to complications during medical procedures if the wrong size is used.
The sheath may be labeled with .018 dilators but contain a .038 dilator instead. This size difference could cause improper fitting during medical procedures, potentially leading to complications.
Healthcare professionals using the Prelude Guide Sheath Roadster for medical procedures are most at risk. Patients receiving this device during procedures may be affected if the incorrect dilator size is used.
Check for the model number PG6F45S018 on the sheath. The product was sold with lot number H2817178 and unique device identifier 00884450770771.
Look for the model number PG6F45S018 and lot number H2817178 on the sheath.
The recall indicates a potential for incorrect dilator size, which could cause complications during procedures. However, the risk is low as the issue is not confirmed to cause serious injury in normal use.
Check for the model number PG6F45S018 and lot number H2817178 on the sheath, or the unique device identifier 00884450770771.
The recall does not specify a remedy, so no action is required beyond checking the product label.
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-1875-2024 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1875-2024 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.
