Maquet recalls specific ECC pack models due to potential sterility issues during sterilization. Affected units may not maintain proper sterility assurance levels if humidity/ethylene oxide gas flow is blocked.
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 certain ECC packs because their design might prevent proper humidity and gas flow during sterilization, risking contamination. This could lead to infections if the equipment is used without proper sterility.
The closed stopcock configuration in these packs may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This can cause the sterility assurance level to fail, potentially leading to contamination and infection.
Healthcare professionals using the Maquet Getinge BO-T 41301 BUMC ECC Pack for extracorporeal circulation. Patients using these packs during medical procedures are at risk of infection if sterility is compromised.
Check for batch numbers: 3000060743, 3000066277, 3000069078, 3000073171, 3000074176, 3000076468, 3000080999, 3000081905, 3000085277. The product is labeled as Maquet Getinge- BO-T 41301 BUMC ECC PACK with material code -701065209R01.
Identify if your unit has any of the listed batch numbers: 3000060743, 3000066277, 3000069078, 3000073171, 3000074176, 3000076468, 3000080999, 3000081905, 3000085277.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination and infection.
Batch numbers: 3000060743, 3000066277, 3000069078, 3000073171, 3000074176, 3000076468, 3000080999, 3000081905, 3000085277.
The recall does not require immediate action, but you should check your batch number and contact Maquet if you have an affected unit.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1662-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1662-2019 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.
