Maquet recalls two ECC packs due to potential sterility issues during sterilization. The closed stopcock design may prevent humidity and ethylene oxide gas from reaching the fluid path, risking contamination.
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 two specific ECC packs that could become contaminated during sterilization because their design might prevent proper humidity and gas flow. This could lead to unsafe medical use if the packs are not properly sterilized.
The closed stopcock design in these packs may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, potentially leading to infections or contamination in medical procedures.
Healthcare professionals using these ECC packs for extracorporeal circulation during medical procedures. Patients using the packs in critical care settings are at risk if the packs become contaminated.
Check for the model numbers 701055490R01 or 701055490R02 on the pack. These ECC packs were sold with batch numbers 3000050886 or 3000066508, 3000081906.
Identify the model number and batch number on the pack to confirm if it is recalled.
The closed stopcock design may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, risking contamination.
The recall does not specify a remedy, so check the product details to confirm if it is recalled and contact the manufacturer for further instructions.
The recall indicates a potential sterility issue, but no specific injury mechanism is described. The risk level is low_risk as the hazard is related to contamination rather than immediate injury.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1653-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1653-2019 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.
