Maquet recalls Getinge-BEQ-T 44200 Mayo Pulmonary P (701064831) due to potential sterility issues during sterilization. Affected units have batch numbers 3000066688 or 3000080800. Contact for remedy.
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 Mayo Pulmonary P devices because their tubing design may fail to ensure sterility during sterilization. This could lead to infections if the equipment is used without proper sterility.
The tubing's closed stopcock design may trap humidity and ethylene oxide gas during sterilization. This prevents proper sterility assurance, potentially allowing contaminants to remain in the device.
Healthcare professionals using the Getinge-BEQ-T 44200 Mayo Pulmonary P device with batch numbers 3000066688 or 3000080800 are most at risk. Patients using these devices could face infection if sterility is compromised.
Check for the model 'Getinge-BEQ-T 44200 Mayo Pulmonary P' with material code 701064831. Affected units have batch numbers 3000066688 or 3000080800.
Identify the model and batch numbers to confirm if your device is affected.
The tubing design may prevent proper sterility assurance during sterilization, risking contamination.
Batch numbers 3000066688 and 3000080800.
The recall does not specify a remedy, so contact Maquet 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-1562-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1562-2019 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.
