Merit Medical recalls custom angiography kits with unsealed sterile bags that could lead to infections. Affected kits may need medical treatment if non-sterile items are exposed. Contact 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 unsealed sterile bags. This could expose users to non-sterile items, increasing infection risk during medical procedures.
The header bags in the kits may not be fully sealed, breaking the sterile barrier. This could let non-sterile items enter the kit, potentially causing infections that require medical treatment.
Healthcare professionals using the custom procedure kits for angiography or angioplasty procedures. Patients undergoing these procedures are at risk if the kits are used with compromised sterility.
Check for Product Code K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only. The lot number T1888031 is also associated with this recall.
Inspect the header bags for signs of being unsealed or compromised.
The header bags may not be fully sealed, risking exposure to non-sterile items and potential infection.
Check the seal on the header bags; if unsealed, contact Merit Medical for guidance.
The recall does not specify a fix; users should check the seal and contact Merit Medical if needed.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0750-2021 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0750-2021 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.
