Merit Medical recalls Prelude Guide Sheath Roadster (PG5F45S018) due to potential inclusion of a .038 dilator instead of .018 in sterile surgical sheaths. Affected units sold with specific lot numbers.
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Merit Medical is recalling their Prelude Guide Sheath Roadster surgical sheaths because some units might contain a .038 dilator instead of the intended .018 size. This could lead to incorrect surgical procedures if used without proper verification.
The sheaths are labeled for .018 dilators but may contain a .038 dilator. Using the wrong size could cause improper surgical procedures or complications during procedures.
Surgical professionals using the Prelude Guide Sheath Roadster for procedures. Those with the specific lot numbers (H2800643) are most at risk.
Check for the model number PG5F45S018 and lot number H2800643 on the sheath packaging. The sheath is sterile, for surgical use only, and labeled as 5F 0.076 (1.9 mm), 45 cm.
Check the model number on the sheath packaging to confirm it is PG5F45S018.
Reach out to Merit Medical Systems for confirmation of the correct dilator size if you have the sheath.
The recall indicates a potential risk of incorrect dilator size, so it is not recommended without verification.
Check the model number and lot number; contact Merit Medical Systems for guidance.
Look for the model number PG5F45S018 and lot number H2800643 on the packaging.
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-1874-2024 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1874-2024 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.
