Maquet recalls Getinge-BEQ-TOP 24202 Adult ECC tubing sets with batch 3000080713 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 adult ECC tubing sets because their design might not maintain sterility during sterilization. This could lead to infections if the tubing is used in medical procedures without proper sterility.
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, potentially allowing contaminants to remain in the tubing.
Healthcare professionals using the Getinge-BEQ-TOP 24202 Adult ECC tubing sets with batch number 3000080713 are most at risk. Patients receiving these sets during medical procedures could face infection risks.
Check for the batch number 3000080713 on the Getinge-BEQ-TOP 24202 Adult ECC tubing sets. The product is labeled with material code 701054295R01.
Look for batch number 3000080713 on the tubing set.
The tubing's design may prevent proper humidity and gas flow during sterilization, risking contamination and compromising sterility assurance.
Check the batch number. If it matches 3000080713, contact Maquet for guidance.
This is a sterility risk, not a direct safety hazard like fire or injury. Proper sterilization protocols should mitigate risks.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1647-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1647-2019 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.
