Maquet recalls Getinge-BEQ-T 28906 1/4" tubing with specific batch numbers due to potential sterility issues during sterilization. Affected units may not maintain proper sterility assurance levels.
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 model of cardiovascular tubing because its design may fail to ensure sterility during sterilization. This could lead to infections if the tubing is used in medical procedures.
During sterilization, the tubing's closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, potentially leading to infections.
Healthcare professionals using this tubing for extracorporeal circulation (ECC) procedures. Patients receiving such treatments are at risk if the tubing is not properly sterilized.
Check for the model number 'Getinge-BEQ-T 28906 1/4"' with the specific batch numbers 3000062737 or 3000068119. This tubing is used in extracorporeal circulation systems.
Verify the batch numbers on the tubing: 3000062737 or 3000068119.
The tubing's design may prevent proper humidity and gas flow during sterilization, risking inadequate sterility assurance.
The recall does not specify a remedy, so check with the manufacturer for guidance.
The recall indicates potential sterility issues during sterilization, so it should not be used until the manufacturer provides instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1599-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1599-2019 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.
