Baxter recalls specific PrismaFlex sets due to potential failure to sterilize, risking infection. Affected units include model numbers 106696, 106697, 107144, and 115307 with certain lot numbers.
Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appear to be conforming
Baxter is recalling certain PrismaFlex medical sets because they may not have been properly sterilized. This could lead to infections if used in medical treatments. The affected products include specific model numbers and lot ranges.
The recall states that products labeled as sterile may not have been sterilized properly. Baxter confirmed that Steril Milano observed nonconformances that were not reported, and data was manipulated to appear conforming. This could result in unsterilized products being used, increasing infection risk.
Healthcare providers using Baxter PrismaFlex sets for renal replacement therapies or continuous fluid management are most at risk. Patients relying on these devices could face infection if the sets are not properly sterilized.
Check for model numbers 106696 (M 60 SET), 106697 (M 100 SET), 107144 (TPE2000 SET), or 115307 (M 150 SET) with specific lot numbers listed in the recall notice.
Identify the model number and lot numbers from the product labels to confirm if it is affected by this recall.
Baxter confirmed that products labeled as sterile may not have been sterilized properly. Steril Milano observed nonconformances that were not reported, and data was manipulated to appear conforming.
Affected model numbers include 106696 (M 60 SET), 106697 (M 100 SET), 107144 (TPE2000 SET), and 115307 (M 150 SET) with specific lot numbers listed in the recall notice.
The recall does not specify a remedy or action to take, so users should check the product model and lot numbers to determine if they are affected.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-2378-2021 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-2378-2021 from Baxter. 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.
