Maquet recalls specific batches of Small Patient Tubing Packs due to potential sterility issues during sterilization. The tubing may not maintain sterility if improperly configured during sterilization processes.
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 certain batches of Small Patient Tubing Packs because the tubing's design could fail to maintain sterility during sterilization. This poses a risk of infection if the tubing is used in medical procedures without proper sterility.
During sterilization, the tubing's closed stopcock configuration may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination of the tubing if used in medical procedures without adequate sterilization.
Healthcare professionals using the recalled tubing for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving such treatments could face infection if the tubing is not properly sterilized.
Check for the product name 'Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack' with batch numbers 3000041414, 3000047036, 3000050575, or 3000051657.
Identify if your tubing pack has batch numbers 3000041414, 3000047036, 3000050575, or 3000051657.
The tubing's closed stopcock configuration may prevent proper flow of humidity and ethylene oxide gas during sterilization, risking contamination.
Look for the product name 'Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack' with batch numbers 3000041414, 3000047036, 3000050575, or 3000051657.
The recall does not require immediate stop use; however, if you have the recalled batch numbers, you should check with your healthcare provider about safe use.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1505-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1505-2019 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.
