Maquet recalls Getinge-BEQ-T 30601 CMC ACCESSORY KIT (batch 3000054160, 3000057639, 3000058046) due to potential sterility issues during sterilization. Affected users should 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 a specific CMC ACCESSORY KIT used in medical devices because it may not maintain sterility during sterilization. This could lead to infections if the kit is used without proper sterility.
During sterilization, the closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could allow contaminants to remain in the kit, increasing infection risk.
Healthcare professionals using this kit for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving treatments with this kit could face infection if sterility is compromised.
Check for batch numbers 3000054160, 3000057639, or 3000058046 on the kit's label. The product is a CMC ACCESSORY KIT from Maquet Getinge-BEQ-T 30601.
Look for batch numbers 3000054160, 3000057639, or 3000058046 on the kit's label.
The recall states that the kit may not maintain sterility during sterilization, so it should not be used until the issue is resolved.
Contact Maquet directly for instructions on how to handle the kit, as the recall remedy is not specified in the record.
Check for batch numbers 3000054160, 3000057639, or 3000058046 on the kit's label.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1558-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1558-2019 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.
