Merit Medical recalls Custom Procedure Kit (Cardiac Cath Pack) due to potential unsealed sterile bags causing infection risk. Affected units have product code K12T-10996 Rev. B. Contact for remedy.
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 procedure kits for cardiac catheterization that may have unsealed sterile bags. This could lead to infections requiring medical treatment if non-sterile items are used during procedures.
The header bags in the kit may not be fully sealed, compromising the sterile barrier. This could allow non-sterile items to enter the procedure, increasing the risk of infection requiring medical treatment.
Healthcare professionals using the kit for angiography or angioplasty procedures are most at risk. Patients undergoing these procedures may be affected if the kit is used without proper sterility.
Check for product code K12T-10996 Rev. B, sterile EO, Rx Only, with lot number T1907711. The kit is used for cardiac catheterization procedures.
Inspect the header bags for signs of being unsealed or compromised.
The recall affects healthcare professionals using the kit. Patients are at risk only if the kit is used without proper sterility.
The official recall notice does not specify a remedy or action steps for affected users.
Check for product code K12T-10996 Rev. B, sterile EO, Rx Only, and lot number T1907711.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0751-2021 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0751-2021 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.
