Maquet Getinge Adult ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific adult extracorporeal circulation tubing sets 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 harm (infection) in a high-risk clinical setting, but no injuries or illnesses have been reported, 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 24500 ADULT ECC tubing sets (Material: 701050253). The recall involves specific batch numbers: 3000041126, 3000053053, 3000054958, 3000055326, 3000064943, 3000066814, and 3000071782. These products were distributed nationwide.
The recall was initiated because the closed stopcock/non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap 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 extracorporeal circulation procedures.
Healthcare facilities and users should identify any affected units by checking the batch numbers listed above. Users should stop using these specific tubing sets and contact Maquet Cardiovascular, LLC for instructions on return or replacement. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253
- 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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