Merit Medical recalls Prelude Sheath Introducer 7.5F models with incorrect 7F labeling that could lead to improper use in medical procedures.
7F sheath introducers labeled as 7.5F
Merit Medical is recalling certain Prelude Sheath Introducer 7.5F models that are labeled as 7F instead of 7.5F. This labeling error could cause improper use during medical procedures, potentially leading to complications.
The sheaths are labeled as 7F when they should be 7.5F. This incorrect labeling could lead to improper use during medical procedures, potentially causing complications.
Healthcare professionals using these sheaths for medical procedures are most at risk. Patients receiving procedures with these sheaths may also be affected.
Check for the model number PSI-7F-11-038 Version F with the specific lot numbers listed on the packaging or documentation. The expiration dates range from February 2027 to May 2027.
Look for the model number PSI-7F-11-038 Version F with lot numbers 00884450708835, 00884450708836, or 00884450708837.
The sheath should be labeled as 7.5F, but some units are incorrectly labeled as 7F.
Check the product label for model number PSI-7F-11-038 Version F with lot numbers 00884450708835, 00884450708836, or 00884450708837.
The recall does not require stopping use; it only identifies the incorrect labeling that may lead to improper use.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3190-2024 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-3190-2024 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.
