Maquet recalls ECC Pump Packs with batch numbers 3000041328 and 3000: Sterility assurance may be compromised during sterilization due to tubing configuration.
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 ECC Pump Packs with specific batch numbers because their tubing design might not allow proper humidity and gas flow during sterilization, risking contamination. This could lead to infections if the pump is used without proper sterility.
The closed stopcock configuration in the tubing may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the pump's sterility assurance level, potentially leading to contamination of the pump components.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 30907 ECC Pump Packs with batch numbers 3000041328 and 3000041619 are most at risk. These pumps are used in extracorporeal circulation systems like heart-lung machines.
Check for batch numbers 3000041328 or 3000041619 on the Maquet Getinge-BEQ-TOP 30907 ECC Pump Packs. The product includes material code 701065770.
Look for batch numbers 3000041328 or 3000041619 on the pump pack.
The recall includes batch numbers 3000041328 and 3000041619.
The tubing design may prevent proper humidity and gas flow during sterilization, risking contamination.
The recall does not specify a remedy; users should check if they have the affected 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-1574-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1574-2019 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.
