Maquet recalls Getinge-BEQ-T 8506 Transport Packs with batch 3000075713 due to potential sterility issues during sterilization. Affected units may not maintain 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 transport packs for extracorporeal circulation use because they might not stay sterile after sterilization. This could lead to infections if used improperly.
During sterilization, the closed stopcock design in these packs may trap humidity and ethylene oxide gas, preventing proper sterilization. This could mean the packs aren't sterile enough for medical use, increasing infection risks.
Healthcare professionals using these transport packs for heart-lung machines during surgery or medical procedures are most at risk. Patients receiving these devices could face infection if the packs aren't properly sterilized.
Check for the model number 8506 and batch number 3000075713 on the transport pack. These packs are used in hospitals for heart-lung machines during surgeries.
Look for the model number 8506 and batch number 3000075713 on the transport pack.
The closed stopcock design may prevent proper sterilization, risking infection during medical procedures.
Check for model number 8506 and batch number 3000075713 on the transport pack.
The recall does not specify a remedy, so contact the manufacturer 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-1606-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1606-2019 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.
