Maquet recalls Getinge-BEQ-TOP 40700 HUNTINGTON tubing sets due to potential sterility issues during sterilization. Affected units have specific batch numbers and material codes.
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 40700 HUNTINGTON tubing sets because their design may prevent proper sterilization, risking contamination. This could lead to infections if used in medical procedures.
The tubing's closed stopcock and non-vented cap design may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This can compromise the sterility assurance level (SAL), potentially leading to contamination.
Healthcare professionals using these tubing sets for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving such treatments could be affected if the tubing is not properly sterilized.
Check for the model 'Getinge-BEQ-TOP 40700 HUNTINGTON' with material code 701062899. Affected units have batch numbers 3000057630 or 3000083783.
Verify the model number and batch numbers listed in the recall notice.
The tubing's design may prevent proper sterilization, risking contamination during medical procedures.
Batch numbers 3000057630 and 3000083783.
Look for the model 'Getinge-BEQ-TOP 40700 HUNTINGTON' with material code 701062899 and the specified batch numbers.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1551-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1551-2019 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.
