Maquet recalls specific small patient circuit tubing sets due to potential sterility failure during sterilization. Affected units have batch numbers 3000043059, 3000051269, 3000067520, 3000072508, 3000080853.
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 small patient circuit tubing sets because improper sterilization could lead to contamination. This affects hospitals and medical facilities using these specific models.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contaminated equipment if the tubing is not sterilized correctly.
Hospitals and medical facilities using the recalled tubing sets are most at risk. Patients receiving treatments with these circuits could be affected if the tubing fails to sterilize properly.
Check for batch numbers 3000043059, 3000051269, 3000067520, 3000072508, or 3000080853 on the tubing packaging. The product is labeled as Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material.
Look for batch numbers 3000043059, 3000051269, 3000067520, 3000072508, or 3000080853 on the tubing packaging.
Batch numbers 3000043059, 3000051269, 3000067520, 3000072508, and 3000080853.
The tubing's design may prevent proper sterilization, risking contamination of medical equipment.
The recall does not specify a stop-use instruction; affected units should be checked for the listed 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-1500-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1500-2019 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.
