Maquet recalls ECC Pump Pack 1/4" (70900: 3000064952) due to potential sterility issues during sterilization. Affected units may not maintain sterility assurance levels.
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 model and batch numbers because sterilization may not properly ensure sterility. This could lead to infections if the pumps are used in medical procedures.
During sterilization, the closed stopcock configuration may block humidity and ethylene oxide gas from reaching the fluid path. This prevents the pump from maintaining sterility assurance levels, potentially allowing contaminants to enter the system.
Healthcare professionals using the Maquet ECC Pump Packs for extracorporeal circulation. Patients receiving these pumps during medical procedures are at risk of infection.
Check for the model number 30914 ECC Pump Pack 1/4" with batch number 3000064952. The product is sold by Maquet Cardiovascular, LLC.
Verify the model number 30914 ECC Pump Pack 1/4" and batch number 3000064952.
The closed stopcock configuration during sterilization may prevent humidity and ethylene oxide gas from reaching the fluid path, potentially compromising sterility assurance levels.
The recall record does not specify a remedy, so check with Maquet Cardiovascular, LLC for further instructions.
The recall indicates a potential sterility risk during sterilization, but the product may still be safe for use if properly sterilized.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1597-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1597-2019 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.
