Maquet recalls specific ECC QUADROX iD Pack RF32 models due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units include batch numbers 3000047630 through 3000074323.
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 certain ECC QUADROX iD Pack RF32 models because their stopcock design may prevent proper sterilization. This could lead to contamination of medical devices during use, posing a risk to patient safety.
The closed stopcock configuration in the tubing may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This prevents the system from achieving proper sterility assurance, potentially contaminating the device and risking infection.
Healthcare professionals using the recalled ECC QUADROX iD Pack RF32 models for extracorporeal circulation are most at risk. Patients receiving treatments with these devices could be exposed to contamination.
Check for the model name 'Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32' and batch numbers 3000047630 through 3000074323. The product is sold for extracorporeal circulation use in medical settings.
Identify the batch number on the product label to confirm if it is in the affected range (3000047630 to 3000074323).
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of the device.
Batch numbers 3000047630, 3000050482, 3000055980, 3000060726, 3000066813, 3000068491, 3000070813, and 3000074323.
No immediate stop is required, but affected units should be checked for the batch numbers listed and handled with caution to avoid contamination risks.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1499-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1499-2019 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.
