Maquet recalls specific circulatory circuit models due to potential sterility issues when sterilized. The closed stopcock design may prevent proper humidity and gas flow, 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 a specific circulatory circuit model because its design may cause sterility problems during sterilization. This could lead to infections if the equipment is used improperly.
The closed stopcock configuration in the tubing may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility of the equipment, increasing infection risks.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit model with batch number 3000077742 are affected. Patients receiving treatments through this equipment face the highest risk.
Check for the model number 'Getinge-BEQ-TOP 15704' and batch number '3000077742' on the product. The item is sold by Maquet Cardiovascular, LLC.
Look for the model number 'Getinge-BEQ-TOP 15704' and batch number '3000077742' on the product.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination.
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, so it is not recommended for use until the issue is resolved.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1639-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1639-2019 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.
