Maquet recalls specific adult custom pack tubing sets for extracorporeal circulation due to potential sterility issues during sterilization. Affected units have batch numbers starting with 3000061104. Contact for remedy 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 adult custom pack tubing sets for extracorporeal circulation because improper sterilization could compromise sterility. This affects medical devices used in heart-lung machines during surgeries. Using these sets without proper sterilization may lead to infections.
During sterilization, the closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level of the stopcock ports, potentially leading to infections if the tubing is used without proper sterilization.
Healthcare professionals using the Maquet Getinge-BEQ-T 27602 709000417 adult custom pack tubing sets for extracorporeal circulation. Patients undergoing heart-lung machine procedures are at risk if the tubing is not properly sterilized.
Check for batch numbers starting with 3000061104 on the Maquet Getinge-BEQ-T 27602 709000417 adult custom pack tubing sets. These sets are used in extracorporeal circulation systems for heart-lung machines.
Look for batch numbers starting with 3000061104 on the tubing set.
The batch numbers start with 3000061104.
Improper sterilization could compromise sterility assurance, potentially leading to infections if the tubing is used without proper sterilization.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1616-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1616-2019 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.
