Maquet recalls two ECC Small-Cardiac tubing sets due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination.
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 two specific ECC Small-Cardiac tubing sets because their design might cause sterility problems during sterilization. This could lead to contaminated medical equipment if not properly sterilized.
The tubing sets have a closed stopcock design that doesn't allow humidity and ethylene oxide gas to flow properly during sterilization. This can prevent the equipment from meeting sterility standards, potentially leading to contamination.
Healthcare professionals using these specific tubing sets for extracorporeal circulation. Patients receiving treatments with these sets may be at risk of infection if the equipment isn't properly sterilized.
Check for model numbers 701067350R01 or 701067350R02 on the tubing sets. These were sold with batch numbers 3000067384, 3000070970 or 3000074734, 3000081003.
Look for model numbers 701067350R01 or 701067350R02 on the tubing sets.
Confirm batch numbers 3000067384, 3000070970 or 3000074734, 3000081003 if applicable.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
The recall indicates a potential sterility risk during sterilization, but the record does not mention immediate injury risks.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1667-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1667-2019 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.
