Maquet recalls specific batches of Getinge-BEQ-T 8805 ECC PACKs 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 specific batches of Getinge-BEQ-T 8805 ECC PACKs because their sterilization process might not properly ensure sterility. This could lead to infections if the equipment is used without proper sterilization.
During sterilization, the closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level of the stopcock ports, potentially leading to infections.
Healthcare professionals using the Getinge-BEQ-T 8805 ECC PACKs for extracorporeal circulation. Patients receiving treatments through these devices are at risk if the equipment isn't properly sterilized.
Check for batch numbers: 3000071966, 3000074121, 3000075280, or 3000077082. The product is labeled as Maquet Getinge-BEQ-T 8805 ECC PACK with material code 701053361.
Look for batch numbers 3000071966, 3000074121, 3000075280, or 3000077082 on the product.
The affected batch numbers are 3000071966, 3000074121, 3000075280, and 3000077082.
The recall record does not specify a remedy.
If the equipment isn't properly sterilized due to the issue, it could lead to infections.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1525-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1525-2019 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.
