Maquet Getinge Adult ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific batches of adult extracorporeal circulation tubing sets because a design feature may prevent proper sterilization gas flow.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the sterility assurance level cannot be verified, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 24202 Adult ECC Custom Tubing Sets. The affected products are identified by batch numbers 3000057379, 3000063707, 3000066885, 3000071785, 3000071806, and 3000073164. The recall is distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the products may not be sterile.
Healthcare facilities and users of these specific tubing sets should stop using the affected batches and contact Maquet Cardiovascular for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295
- Manufacturer
- Maquet Cardiovascular, LLC
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 183 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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