Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation 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 is classified as FDA Class II, and the hazard involves a potential failure of sterilization in a medical device used for extracorporeal circulation, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific lots of Maquet Getinge-BEQ-TOP 25003 custom tubing sets used for extracorporeal circulation. The recall is due to a potential defect in the closed stopcock and non-vented cap configuration. During the sterilization process, this 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.
The affected product is identified by the following batch numbers: 3000041007, 3000044052, 3000045730, 3000047318, 3000054334, 3000054615, and 3000063091. The material code is 701063255. The product was distributed nationwide.
Healthcare facilities and users should check their inventory for these specific batch numbers and stop using the affected tubing sets. Users should contact Maquet Cardiovascular, LLC for further instructions on how to return or dispose of the recalled product.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255
- 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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