Maquet Getinge BEQ-TOP 5210 ECC Set Recall for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific BEQ-TOP 5210 ECC Sets 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 the sterility assurance level cannot be verified, creating a risk of harm from potential contamination, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge BEQ-TOP 5210 ECC Set - Respiratory Material (Material: 701055604R01). The recall affects specific batch numbers: 3000044876, 3000047906, 3000051750, 3000056130, 3000061303, 3000062457, and 3000071820. The products were distributed nationwide.
The recall is due to a potential issue with the closed stopcock/non-vented cap configuration. During the sterilization process, this configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
Healthcare facilities and users should identify any affected units by checking the batch numbers listed above. Users should stop using the affected sets and contact Maquet Cardiovascular, LLC for further instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01
- 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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