Maquet recalls Getinge-BEQ-T 52301 sash packs with batch numbers 3000053797-3000075716 due to potential sterility issues during sterilization. Affected users should check their batch numbers and contact Maquet for details.
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 specific sash and accessory packs for extracorporeal circulation use because improper sterilization could compromise sterility. This risk affects medical devices used in heart-lung machines during surgeries.
The closed stopcock design in these packs may trap moisture and ethylene oxide gas during sterilization. This can lead to reduced sterility assurance, potentially causing infections in surgical procedures.
Healthcare professionals using the Getinge-BEQ-T 52301 sash packs for heart-lung machines during surgery. Patients undergoing procedures with these devices are at risk if the packs are not properly sterilized.
Check the batch numbers on the sash pack: 3000053797, 3000057760, 3000063952, 3000067187, 3000069726, 3000072683, or 3000075716. The product is sold under the Maquet Getinge-BEQ-T 52301 brand.
Look for batch numbers 3000053797, 3000057760, 3000063952, 3000067187, 3000069726, 3000072683, or 3000075716 on the sash pack.
The recalled product is the Maquet Getinge-BEQ-T 52301 Sash & Accessory Pack with batch numbers 3000053797-3000075716.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking reduced sterility assurance.
The recall does not require immediate discontinuation; users should check batch numbers and contact Maquet for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1678-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1678-2019 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.
