Maquet Getinge-T AV Manifold Recall Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific AV Manifold units for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.
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 medical device where sterility cannot be assured, creating a risk of harm from potential contamination. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-T 41303 AV Manifold for Extracorporeal Circulation (ECC). The recall affects units with batch numbers 3000041542, 3000046483, 3000049065, 3000055328, 3000057682, 3000060483, and 3000063712. These products were 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, potentially compromising the sterility of the device.
Healthcare facilities and users should stop using the affected units and contact Maquet Cardiovascular for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551
- 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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