Merit Medical recalls Custom Procedure Kit REF K12T-11077 with 7F sheath introducers labeled as 7.5F. This mismatch may cause improper use during medical procedures.
7F sheath introducers labeled as 7.5F
Merit Medical is recalling a Custom Procedure Kit (REF: K12T-11077) because some sheath introducers are labeled 7.5F instead of 7F. This mismatch could lead to improper use during medical procedures if the wrong size is used.
The sheath introducers are labeled as 7.5F instead of 7F. This size mismatch could cause improper use during medical procedures if the wrong size is used, potentially leading to incorrect procedure outcomes.
Medical professionals using the Custom Procedure Kit with the specific reference number K12T-11077 are likely affected. The risk is low as this is a labeling error rather than a safety hazard.
Check for the reference number K12T-11077 on the kit. The expiration date is December 1, 2024, and the lot number is 00884450457863.
Look for the reference number K12T-11077 and expiration date December 1, 2024.
No, this is a labeling error that could lead to improper use during medical procedures, but it does not pose a direct safety hazard.
Check for the reference number K12T-11077 with expiration date December 1, 2024 and lot number 00884450457863.
The recall does not specify a remedy, so no action is required beyond checking the product label.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-3191-2024 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-3191-2024 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.
