Maquet recalls Getinge-BEQ-TOP 5909 tubing sets due to potential sterility issues during sterilization. Affected units have specific batch numbers. 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 certain Getinge-BEQ-TOP 5909 tubing sets because their design may prevent proper sterilization, risking infection. This affects medical devices used in extracorporeal circulation systems.
The tubing's closed stopcock configuration can block humidity and ethylene oxide gas from reaching the fluid path during sterilization. This may compromise the sterility assurance level, potentially leading to infections.
Healthcare professionals using extracorporeal circulation systems (like ECMO) may be affected. Patients using these devices face the lowest risk of infection due to the specific design flaw.
Check for the model number 'Getinge-BEQ-TOP 5909 1/4 PACK W QPID' and batch numbers listed: 3000043679, 3000047252, 3000050833, 3000053134, 3000054956, 3000056048, 3000060481, 3000063710, 3000067185, 3000071400, 3000073429, 3000075387, 3000075899.
Identify the model number and batch numbers listed in the recall notice.
The recalled model is Getinge-BEQ-TOP 5909 1/4 PACK W QPID with batch numbers 3000043679 through 3000075899.
The tubing's design may prevent proper humidity and gas flow during sterilization, risking infection.
The recall notice does not specify a remedy; contact Maquet 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-1566-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1566-2019 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.
