Maquet Getinge AV Loop Tubing Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific AV Loop 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, posing a risk of infection (risk-of-harm product) without reported injuries, which aligns with the 'High' severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP tubing sets. The recall affects specific batch numbers: 3000043295, 3000047248, 3000047254, 3000055638, 3000062271, 3000065551, 3000069074, and 3000075386. The product was distributed nationwide.
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. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially leaving the device non-sterile.
Healthcare facilities and users should check their inventory for the affected batch numbers. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776
- 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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