Centurion Medical Products recalls specific LVAD maintenance kits due to potential sterility compromise from incomplete sterile package seals. Affected kits include DM1005, DM280A, DM320, and others with listed lot codes. No remedy specified in recall notice.
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 might not seal properly, risking contamination. This could lead to infections or other complications for patients using these life-support devices.
The sterile packaging for these medical kits may have incomplete seals, which could allow contaminants to enter the kit. This poses a risk of infection or other complications for patients relying on these life-support devices.
Patients using left ventricular assist devices (LVADs) with the recalled kits are most at risk. Healthcare providers who handle these kits during patient care may also be affected.
Check for kit names like DM1005, DM280A, DM320, or others listed in the recall. Look for lot codes such as 2019030480, 2019010790, or 2018122890 on the packaging.
Look for specific kit names and lot codes on the packaging to confirm if your kit is affected.
The recall states that incomplete seals may compromise sterility, so affected kits should not be used until replaced with a confirmed safe kit.
Check the kit name and lot code on the packaging. Affected kits include DM1005, DM280A, DM320, and others with specific lot codes listed in the recall notice.
The recall notice does not specify a remedy; affected kits should be checked and replaced with a confirmed safe kit.
We’ve drafted a message you can send Centurion to request your refund or repair — edit it as you like.
Subject: Recall Z-1073-2020 — Centurion Centurion Hello, I own a Centurion that is covered by recall Z-1073-2020 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.