Medline recalls convenience kits with potential sterility issues due to calibration problems in sterilization packaging. Affected models include DM1035 and DM1035A trays and DT8670A dressing trays. Check serial numbers for recall lots.
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 specific convenience kits that may not be sterile due to calibration issues in the sterilization process. This could lead to infections if used in medical settings. Affected items include LVAD driveline trays and central line dressing trays with specific model numbers and production dates.
The calibration issues in the sterilization process might compromise the sterility assurance level of the kits. This means the kits could become contaminated during packaging, increasing infection risk for medical procedures.
Healthcare professionals using these kits for medical procedures are most at risk. Patients receiving treatments with these kits could face infection if the items are not properly sterile.
Check for model numbers DM1035, DM1035A, or DT8670A on the kits. Look for lot numbers from 2020042290 to 2025051290 in the product description.
Review the model number and lot number on the kit to confirm if it's affected by this recall.
Medline identified calibration issues in the sterilization process that could impact the sterility assurance level of the kits.
LVAD Driveline Trays (DM1035 and DM1035A) and Central Line Dressing Change Trays (DT8670A) with specific lot numbers from 2020042290 to 2025051290.
Check the model number and lot number on your kit. If it matches the recalled items, contact Medline for further instructions.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2125-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2125-2026 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.
