Trinity Sterile recalls Midline Catheter Dressing Change Kits with Statlock due to face masks or materials in the seal, risking infection. Affected kits have Product Number TRIO0000l and Lot Number 60:0001.
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Trinity Sterile is recalling Midline Catheter Dressing Change Kits with Statlock because some kits have face masks or other materials in the seal, which can cause improper sealing and compromise sterility. This risk could lead to infections if the catheter is not properly maintained.
The kits may contain face masks or other materials in the seal, which can cause improper sealing. This compromises sterility, increasing the risk of infection during catheter maintenance procedures.
Healthcare professionals who use these kits for vascular catheter maintenance are most at risk. Patients receiving catheter care through these kits could also be affected if the seal is compromised.
Check for Product Number TRIO0000l and Lot Number 600001 on the kit packaging. The kits were sold starting April 30, 2022.
Look for Product Number TRIO0000l and Lot Number 600001 on the kit packaging.
The kits may have face masks or other materials in the seal, causing improper sealing and compromised sterility, which could lead to infections.
Check for Product Number TRIO0000l and Lot Number 600001 on the kit packaging. The kits were sold starting April 30, 2022.
The recall record does not specify a remedy, so contact Trinity Sterile directly for guidance.
We’ve drafted a message you can send Trinity Sterile to request your refund or repair — edit it as you like.
Subject: Recall Z-1468-2021 — Trinity Sterile Trinity Sterile Hello, I own a Trinity Sterile that is covered by recall Z-1468-2021 from Trinity Sterile. 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.