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. The hazard involves a potential failure of sterilization assurance (SAL) for a medical device used in extracorporeal circulation, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific lots of Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC tubing sets used for extracorporeal circulation. The recall is due to a potential issue with the closed stopcock and non-vented cap configuration. This design may prevent the flow of humidity and ethylene oxide gas into the fluid path during the sterilization process, meaning the Sterility Assurance Level (SAL) for the stopcock ports cannot be guaranteed.
The affected product is distributed nationwide. The specific batch numbers involved in this recall are 3000043291, 3000044425, 3000046811, 3000047912, 3000052203, 3000053795, 3000059174, 3000062478, 3000066197, 3000067469, 3000070703, 3000074122, and 3000075895. The material code for the product is 701054438.
Healthcare facilities and users should check their inventory for these specific batch numbers. If the product is found, it should be removed from service and returned to the manufacturer or disposed of according to local regulations. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438
- 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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