Merit Medical recalls Cultura Flex Swab (Ref C100F) due to flocked tip breaking off during use, potentially causing soft tissue injury or treatment delays. Affected units sold before August 28, 2020.
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
Merit Medical is recalling their Cultura Flex Swab sterile collection device because its flocked tip might break off in the nasal passage during sample collection. This could cause soft tissue injury or delay medical treatment. The recall affects specific units sold before August 28, 2020.
The flocked tip of the swab may break off inside the nasal passage during sample collection. This can cause soft tissue injury or delay medical treatment if the broken tip is not properly removed.
Healthcare professionals using the swab for nasal sample collection are most at risk. Patients receiving nasal swabs from this device could experience injury or treatment delays.
Check for the model number 'C100F' on the swab packaging. Units sold before August 28, 2020 are affected. The serial numbers listed in the recall notice include specific batch codes.
Look for the model number 'C100F' and serial numbers matching those listed in the recall notice.
The flocked tip may break off during sample collection, potentially causing soft tissue injury or delaying treatment.
The recall notice does not specify a remedy; check the packaging for the model number and serial numbers to confirm if it's affected.
Yes, the broken tip could cause soft tissue injury or delay medical treatment if not properly handled.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0454-2021 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0454-2021 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.
