Maquet recalls specific ECC 3/8 in AV loops with batch 3000079891 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 a specific blood circulation loop model because it may not stay sterile after sterilization. This could lead to infections if used in medical procedures.
During sterilization, the closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the loop is used without being fully sterile.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop with batch number 3000079891 are most at risk. Patients receiving this equipment during medical procedures could be affected.
Check for the batch number 3000079891 on the product label. The product is a Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop with Qx-iD material.
Look for the batch number 3000079891 on the product label to confirm if it is affected.
The recall does not state that the product is safe to use; it may not meet sterility standards after sterilization.
The recall record does not specify a remedy, so no action is required beyond checking the batch number.
Check for the batch number 3000079891 on the product label.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1642-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1642-2019 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.
