Maquet Getinge Adult ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific adult extracorporeal circulation tubing 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 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 24202 ADULT ECC tubing sets (Material: 701054295R01) with Batch Number 3000080713. The recall is due to a potential issue with the sterilization process for these devices.
During sterilization, the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the devices may not be fully sterile.
The affected products were distributed nationwide. Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions or replacement.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01
- 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: 3000080713
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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