Merit Medical recalls Prelude Short Sheath Introducer (REF: PSS-6F-4-018MT) due to potential incorrect dilator in package. This may cause complications during medical procedures. Affected units were sold with specific model and lot numbers.
There is a potential that a package sheath contains an incorrect dilator.
Merit Medical is recalling their Prelude Short Sheath Introducer (model PSS-6F-4-018MT) because some packages might contain the wrong dilator. This could lead to complications during medical procedures if used incorrectly.
The recall is for a potential incorrect dilator in the package. If the wrong dilator is used during a medical procedure, it could cause complications. This is a manufacturing issue that affects the device's safety.
Healthcare professionals using this medical device for procedures are most at risk. Patients receiving the device during medical treatments may be affected if the incorrect dilator is used.
Check for the model number PSS-6F-18MT on the device. The product was sold with specific lot number H2069291 and was manufactured with sterile packaging.
Look for the model number PSS-6F-4-018MT on the device packaging or label.
The recall indicates a potential issue with the dilator in the package, so it is not recommended to use until the recall is addressed.
Check the model number on the device packaging or label. If it matches PSS-6F-4-018MT, contact Merit Medical for further instructions.
The recall states there is a potential for incorrect dilator, which could cause complications during procedures, but the severity is not specified as life-threatening.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2243-2021 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-2243-2021 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.
