Maquet Getinge Circulatory Circuits Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific circulatory circuits because a design feature may prevent proper sterilization, potentially compromising sterility.
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 infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 15704 Circulatory Circuits (Material: 701050859R01) with Batch Number 3000077742. These products are used for extracorporeal circulation.
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, which poses a risk of non-sterile components being used in medical procedures.
The affected products were distributed nationwide. Healthcare facilities and users should stop using the affected units and contact Maquet Cardiovascular for further instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01
- Manufacturer
- Maquet Cardiovascular, LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch Numbers: 3000077742
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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