Maquet recalls Getinge-BEQ-T 52301 sash packs with batch numbers 3000044290 and 3000046395 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 specific sash and accessory packs used in medical sterilization because they might not stay sterile after processing. This could lead to infections if the equipment isn't properly sterilized.
During sterilization, the closed stopcock design in these packs may block humidity and ethylene oxide gas from flowing into the fluid path. This can cause the equipment to fail sterility checks, potentially leading to infections.
Healthcare facilities using the recalled sash and accessory packs for medical sterilization are most at risk. Patients and staff could face infection if the equipment isn't properly sterilized.
Check for batch numbers 3000044290 or 3000046395 on the sash and accessory packs labeled as Maquet Getinge-BEQ-T 52301. The product includes material code 709000266.
Look for batch numbers 3000044290 or 3000046395 on the sash and accessory packs.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking sterility assurance.
Check for batch numbers 3000044290 or 3000046395 on the Maquet Getinge-BEQ-T 52301 sash and accessory packs with material code 709000266.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1608-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1608-2019 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.
