Merit Medical recalls Prelude SNAP Splittable Sheath Introducer (7F, 13cm) due to potential packaging error where 7F sheaths may be labeled as 10F. This could cause incorrect use in medical procedures.
There is a potential that 7F sheaths are packaged as 10F sheaths.
Merit Medical is recalling their Prelude SNAP Splitt:able Sheath Introducer (7F, 13cm) because some units might be packaged as 10F sheaths. This confusion could lead to incorrect medical procedures if used with the wrong size.
The recall addresses a potential packaging error where 7F sheaths might be labeled as 10F sheaths. This could lead to using the wrong size device during medical procedures, which might not fit properly or cause complications.
Healthcare providers who use this device for medical procedures may be affected. Patients receiving procedures with this device could be at risk if the wrong size is used.
Check for the product name 'Prelude SNAP Splittable Sheath Introducer', size 7F, and standard length 13 cm. The device has a unique identifier (UDI) starting with (01) 00884450467985.
Look for the product name, size 7F, and standard length 13 cm on the device label.
The recall is due to a potential packaging error where 7F sheaths might be labeled as 10F sheaths, which could lead to incorrect use in medical procedures.
Check for the product name 'Prelude SNAP Splittable Sheath Introducer', size 7F, and standard length 13 cm. The device has a unique identifier (UDI) starting with (01) 00884450467985.
The recall does not specify a remedy, so check with your healthcare provider or the manufacturer for guidance.
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-2239-2021 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-2239-2021 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.
