Z-Medica recalls QuikClot Combat Gau: Model 200 may have packaging seal breaches causing sterile barrier failure. Stop using if you own this product.
Lack of Packaging seal integrity may result in a sterile barrier breach.
Z-Medica is recalling QuikClot Combat Gauze Model 200 due to potential packaging seal failures that could compromise sterility. This risk matters because it might lead to infection if the gauze is used for bleeding control.
The packaging seal may fail, allowing contaminants to enter the sterile gauze. This could cause infection if the gauze is used to control bleeding. The risk is specific to products without proper seal integrity.
People who own or use QuikClot Combat Gauze Model 200 for temporary bleeding control are affected. Those with medical conditions requiring sterile applications may be at higher risk.
Check for the model number 200 on the packaging. The product was sold with lot number 12645 and UDI primary number 00841495102004.
Inspect the packaging for any signs of seal failure or damage.
The recall indicates potential packaging seal issues that could compromise sterility, so it's not recommended for use until confirmed safe.
Look for model number 200 on the packaging, lot number 12645, or UDI primary number 00841495102004.
Check the packaging seal for damage; if unsure, stop using and contact Z-Medica for guidance.
We’ve drafted a message you can send Z-Medica to request your refund or repair — edit it as you like.
Subject: Recall Z-0211-2022 — Z-Medica Z-Medica Hello, I own a Z-Medica that is covered by recall Z-0211-2022 from Z-Medica. 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.