Maquet recalls Getinge-BEQ-TOP 4901 tubing sets with batch numbers 3000063714 and 3000080869 due to potential sterility issues during sterilization. Affected users should check their batch numbers and contact Maquet for details.
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 specific Getinge-BEQ-TOP 4901 tubing sets that may not maintain sterility during sterilization. This could lead to infections if the tubing is used in medical procedures without proper sterility.
During sterilization, the tubing's closed stopcock and non-vented cap design may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, increasing infection risk during medical procedures.
Healthcare professionals using the Getinge-BEQ-TOP 4901 tubing sets for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving these procedures could be affected if the tubing is not properly sterilized.
Check for batch numbers 3000063714 or 3000080869 on the Getinge-BEQ-TOP 4901 tubing sets. The product is sold under Maquet Cardiovascular, LLC.
Look for batch numbers 3000063714 or 3000080869 on the tubing sets.
The Getinge-BEQ-TOP 4901 tubing sets with batch numbers 3000063714 and 3000080869.
The tubing's design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking infection.
Check the batch numbers and contact Maquet Cardiovascular, LLC for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1510-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1510-2019 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.
