Centurion Medical Products recalls specific LVAD maintenance kits due to incomplete sterile package seals that may compromise sterility. Affected kits include DM1005, DM280A, DM320, and others with listed lot numbers. Consumers should check their kits and contact Centurion for details.
Incomplete seals on the sterile package may compromise the sterility
Centurion Medical Products is recalling several LVAD (left ventricular assist device) maintenance kits because the sterile packaging may have incomplete seals, risking contamination. This is serious for patients who rely on these devices for heart support, as contamination could lead to infections.
Incomplete seals on the sterile packaging could allow contaminants to enter the kit, potentially causing infections in patients who use the LVAD system. This is especially dangerous because LVADs are used for life support in patients with severe heart failure.
Patients using Centurion LVAD maintenance kits are most at risk, as these devices support heart function in critical cases. Healthcare providers who handle the kits may also be affected if they use the recalled products.
Check for kit names like DM1005, DM280A, DM320, or DM380 with lot numbers listed in the recall (e.g., 2019030480). These kits were sold between 2018 and 2019 for patients needing heart support.
Look for the kit name and lot number on the packaging to determine if it's affected.
Reach out to Centurion Medical Products for specific guidance on the recalled kits and next steps.
No, only specific kits with listed lot numbers (e.g., DM1005 lot 2019030480) are affected.
Check the kit name and lot number on the packaging; affected kits include DM1005, DM280A, DM320, and others with the listed lot numbers from 2018-2019.
The recall does not require immediate stop-use; you should check the kit and contact Centurion for instructions.
We’ve drafted a message you can send Centurion to request your refund or repair — edit it as you like.
Subject: Recall Z-1063-2020 — Centurion Centurion Hello, I own a Centurion that is covered by recall Z-1063-2020 from Centurion. 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.
