Merit Medical recalls Prelude SNAP Splittable Sheath Introducer (REF: PLSX-1:10F) due to potential packaging error where 7F sheaths are shipped as 10F. This may 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 Splittable Sheath Introducer (size 10F) because it might be packaged incorrectly as 10F when it's actually a 7F sheath. This could lead to improper use during medical procedures if the wrong size is used.
The recall addresses a packaging error where 7F sheaths are mistakenly labeled as 10F. Using the wrong size could lead to improper placement of medical devices during procedures, potentially causing complications.
Healthcare professionals who use this device for cardiac procedures may be affected. Patients receiving procedures with this device could be at risk if the incorrect size is used.
Check for the product code REF: PLSX-1010, size 10F, standard length 13 cm, CE0344, and sterile packaging. The lot number I2067768 is also associated with this recall.
Verify the product code, size, and lot number to confirm if it matches the recalled items.
The recall is due to a potential packaging error where 7F sheaths are shipped as 10F, which could lead to incorrect use during medical procedures.
Check for the product code REF: PLSX-1010, size 10F, standard length 13 cm, CE0344, and sterile packaging with lot number I2067768.
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-2238-2021 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-2238-2021 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.
