Maquet recalls specific priming lines for extracorporeal circulation due to potential sterility issues during sterilization. Affected units have batch numbers 3000062472 and 3000071380. Contact for remedy.
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
Maquet is recalling priming lines used in extracorporeal circulation systems because they may not maintain sterility during sterilization. This could lead to infections if the lines are not properly sterilized.
The closed stopcock design may trap humidity and ethylene oxide gas during sterilization. This prevents proper sterility assurance, increasing infection risk after use.
Healthcare professionals using these priming lines in medical procedures are most at risk. Patients using the equipment could face infection if the lines are not properly sterilized.
Check for batch numbers 3000062472 or 3000071380 on the product label. The product is labeled as Maquet Getinge-BO-T 41302 PRIMING LINES BUMC with material code 701066291.
Look for batch numbers 3000062472 or 3000071380 on the product label.
The recalled model is Maquet Getinge-BO-T 41302 PRIMING LINES BUMC with material code 701066291.
Batch numbers 3000062472 and 3000071380 are affected.
The recall addresses a potential sterility issue during sterilization, which could lead to infections if the lines are not properly sterilized.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1577-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1577-2019 from Maquet. 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.
