Maquet recalls Getinge-BEQ-TOP 8208 ECC packs with batch numbers 3000042989 and 3000058142 due to potential sterility issues during sterilization. Affected units may not meet sterility standards if humidity/ethylene oxide gas cannot flow properly.
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 ECC packs that could fail sterility checks during sterilization. This means medical devices might not be safe for use after sterilization, risking infections.
During sterilization, the closed stopcock design may block humidity and ethylene oxide gas from flowing into the fluid path. This prevents the system from achieving proper sterility assurance, potentially leading to infections.
Healthcare professionals using these ECC packs for extracorporeal circulation systems. Patients using the packs during medical procedures may be at risk of infection if the packs are not properly sterilized.
Check for batch numbers 3000042989 or 3000058142 on the Maquet Getinge-BEQ-TOP 8208 ECC packs. The product is sold as a 3/8 inch ECC pack with material code 701068798.
Look for batch numbers 3000042989 or 3000058142 on the product label.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking inadequate sterility assurance.
Check the batch numbers on the product label. If they match 3000042989 or 3000058142, contact Maquet for further instructions.
The product may not meet sterility standards if used without proper sterilization, potentially leading 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-1594-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1594-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
