Merit Medical recalls COBRA-OS custom sheath kits with incorrect needle size that could cause injury during medical procedures. Affected kits have specific lot numbers and were sold with a sterile, single-use label.
Custom sheath Introducer contains incorrect needle size
Merit Medical is recalling custom sheath introducer kits that contain the wrong needle size. This could lead to injury during medical procedures if the kit is used as intended.
The sheath introducer kit contains a needle size that is not what the medical procedure requires. This mismatch could cause injury during insertion or use in the body. Using the wrong needle size may lead to complications like bleeding or tissue damage.
Healthcare professionals using the COBRA-OS sheath kits for medical procedures are most at risk. Patients receiving these kits could be injured if the incorrect needle size causes complications.
Check for the lot number H2122096S1 on the kit packaging. The product is labeled as 'Sterile EO, Single Use, RX Only, 5 Units' with the model REF: E01P2.
Verify the lot number H2122096S1 and model REF: E01P2 on the kit packaging.
The recall states the kit contains an incorrect needle size, which could cause injury during medical procedures. Do not use the kit until you confirm it is not affected.
Check the lot number on the packaging. If it matches H2122096S1, contact Merit Medical for instructions on how to handle the kit.
Look for the lot number H2122096S1 and model REF: E01P2 on the kit packaging. The product is labeled as 'Sterile EO, Single Use, RX Only, 5 Units'.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1578-2023 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1578-2023 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.
