Maquet recalls Getinge-BEQ-T 49002 ROTAFLOW Support Pack (Batch 3000044421) 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 support pack used in medical devices because it may not maintain sterility during sterilization. This could lead to infections if the device is used without proper sterility.
During sterilization, the closed stopcock configuration in this support pack may prevent humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level, potentially leading to infections if the device is used without proper sterility.
Healthcare professionals using the Getinge-BEQ-T 49002 ROTAFLOW Support Pack for extracorporeal circulation. Patients receiving treatments with this equipment are at risk if sterility is compromised.
Check for the Getinge-BEQ-T 49002 ROTAFLOW Support Pack with batch number 3000044421. The product is sold by Maquet Cardiovascular, LLC.
Identify the batch number on the support pack to confirm if it is affected (batch 3000044421).
The recall indicates a potential sterility risk during sterilization, so it is not recommended for use until the remedy is applied. However, the remedy is not specified in the record.
The recall record does not specify a remedy, so contact Maquet Cardiovascular, LLC for guidance.
Check for the batch number 3000044421 on the Getinge-BEQ-T 49002 ROTAFLOW Support Pack.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1584-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1584-2019 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.
