Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design configuration may prevent proper sterilization of 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 harm from potential contamination, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material (Material: 701064590) custom tubing sets for extracorporeal circulation. The recall is limited to Batch Number 3000071399, which 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 between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured during the sterilization process.
Healthcare facilities and consumers who have this specific product should stop using it and contact Maquet Cardiovascular for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590
- 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: 3000071399
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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