Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths.
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. The hazard involves a potential failure to achieve sterility assurance in a medical device used for extracorporeal circulation, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388 custom tubing sets for extracorporeal circulation. The recall is due to a potential issue with 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 non-vented cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
The affected products were distributed nationwide. The recall includes specific batch numbers: 3000044291, 3000046812, 3000048395, 3000051270, 3000054144, 3000055979, 3000058735, 3000061304, 3000063708, 3000066691, 3000070702, 3000072307, and 3000075122.
Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions on the recall process.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388
- 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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