Maquet recalls specific custom ECC tubing sets due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch number 3000078943.
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 custom ECC tubing sets that could become contaminated during sterilization because the stopcock design prevents proper humidity and gas flow. This means the tubing might not be sterile after processing, which is dangerous for medical use.
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 prevents the tubing from achieving the required sterility assurance level, increasing the risk of contamination.
Healthcare professionals using these specific tubing sets for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving treatments with these sets could face infection if the tubing isn't properly sterilized.
Check for the model number 'Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8' and batch number 3000078943 on the packaging or label.
Look for the model number 'Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8' and batch number 3000078943 on the packaging or label.
The closed stopcock and non-vented cap design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination and reducing sterility assurance.
The recall record does not specify a remedy, so contact Maquet directly for guidance.
The recall indicates a potential sterility risk during sterilization, so it should not be used until the manufacturer provides instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1675-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1675-2019 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.
