Merit Medical recalls Cultura Collection and Transport System (Ref CFTS100) for potential soft tissue injury during sample collection. 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 Collection and Transport System swabs because the swab tip might break off in the nasal passage during use, causing injury or delaying treatment. This affects specific units sold before August 28, 2020.
The flocked tip of the 100mm swab can break off inside the nasal passage during sample collection. This may cause soft tissue injury or delay treatment because the broken tip could obstruct the passage or cause irritation.
Healthcare professionals using the Cultura system for sample collection are most at risk. Patients using the system for nasal swabs may experience injury or treatment delays.
Check for the product code CFTS100 on the packaging. Units sold before August 28, 2020 are affected. The serial numbers listed include (01)00884450492123 for 1 unit, (01)10884450492120 for 50 units, and (01)20884450492127 for 200 units.
Look for the serial numbers (01)00884450492123, (01)10884450492120, or (01)20884450492127 on the packaging.
Reach out to Merit Medical for specific instructions on how to handle affected units.
The product may cause soft tissue injury during use if the swab tip breaks off, so it's not safe without checking for affected units.
Check the serial numbers on the packaging: (01)00884450492123 for 1 unit, (01)10884450492120 for 50 units, or (01)20884450492127 for 200 units. Units sold before August 28, 2020 are affected.
Contact Merit Medical for instructions on handling affected units. They may provide a remedy or guidance.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0455-2021 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0455-2021 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.
