Medline recalls specific convenience kits due to potential sterility risks from calibration problems during sterilization. Affected items include LVAD driveline trays and central line dressing trays with model numbers DM1035A, DM1035, and DT8670A.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline is recalling certain convenience kits that could have been contaminated during sterilization due to calibration issues. This affects medical devices used in hospitals and clinics, where sterility is critical for patient safety.
The calibration issues during sterilization could compromise the sterility assurance level of the kits. This means the products might not be sterile when used, potentially leading to infections if they come into contact with patients.
Healthcare facilities and medical professionals who use the recalled convenience kits for patient care. The risk is highest for those handling sterile equipment in clinical settings.
Check for model numbers DM1035A, DM1035, or DT8670A on the kits. The lot numbers listed in the recall include dates from 2020 to 2025. These kits were sold by Medline Industries, LP.
Identify the model number and lot number on the kit to confirm if it is affected.
Medline identified calibration issues that could impact the sterility assurance level during sterilization and packaging of the products.
The recalled products include LVAD driveline trays (model DM1035A and DM1035) and central line dressing change trays (model DT8670A).
Check the model number and lot number on the kit. Affected kits have model numbers DM1035A, DM1035, or DT8670A with specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1411-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1411-2026 from Medline. 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.
