Maquet recalls 3/8" ECC Pack material 701049346R01 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 3/8" ECC Pack model because it may not maintain sterility during 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 allow contaminants to remain in the fluid path, increasing infection risk.
Healthcare professionals using this specific ECC pack for extracorporeal circulation systems. Patients receiving such procedures are at risk if the pack fails to meet sterility standards.
Check for the model number 17207 and material code 701049346R01 on the pack. Affected units were manufactured with batch number 3000079611.
Identify the model number 17207 and material code 701049346R01 on the pack.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination.
The recall record does not specify a remedy, so contact Maquet for guidance.
The recall indicates potential sterility issues, so it should not be used until confirmed safe by the manufacturer.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1631-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1631-2019 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.
