Maquet Getinge Adult ECC Pack Tubing Sets Recalled for Sterility 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) even though no injuries have been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific lots of Maquet Getinge BEQ-TOP 46700 Adult ECC Packs. The recall involves custom tubing sets used for extracorporeal circulation (ECC). The affected batch numbers are 3000076856 and 3000077891, and the product was distributed nationwide.
The recall is due to a potential sterilization defect. During the sterilization process, the closed stopcock and non-vented cap configuration may prevent humidity or ethylene oxide gas from flowing into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured, meaning the sterility of these components is not guaranteed.
Healthcare facilities and consumers who have these specific products should stop using them and contact Maquet Cardiovascular for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01
- 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: 3000076856 3000077891
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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