Merit Medical recalls custom angiography kits due to potential non-sterile devices causing infections. Affected kits may have compromised sterile barriers. Consumers should contact Merit Medical for details.
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment.
Merit Medical is recalling custom angiography kits that may have compromised sterile barriers. This could lead to infections requiring medical treatment if non-sterile devices are used during procedures.
The header bags in the kits may not be fully sealed, creating a compromised sterile barrier. This could allow non-sterile devices to enter the kit, increasing the risk of infection during medical procedures.
Healthcare professionals using the custom kits for angiography or angioplasty procedures are most at risk. Patients receiving these procedures may also be affected if the kits are used without proper sterility.
Check for the product code K05T-02533 on the kit. The lot number T1883210 is associated with this recall. The kits are for angiography or angioplasty procedures.
Reach out to Merit Medical Systems for specific instructions on how to handle the recalled kit.
The header bags may not be fully sealed, leading to a compromised sterile barrier and potential exposure to non-sterile devices.
Using the kit could lead to infections requiring medical treatment if non-sterile devices are introduced during procedures.
Look for the product code K05T-02533 and lot number T1883210 on the kit.
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-0749-2021 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-0749-2021 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.
