Maquet Getinge Custom Tubing Sets Recalled Due to 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 involves a medical device where sterility cannot be assured, creating a risk of infection. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 4903 Mercy Med custom tubing sets for extracorporeal circulation. The recall involves specific batch numbers, including 3000041468, 3000053105, 3000054552, 3000057683, 3000059795, 3000065086, 3000067186, 3000069077, 3000071375, 3000072684, 3000074341, 3000075431, 3000078942, 3000080722, 3000081524, and 3000084050. The products were distributed nationwide.
The recall is due to a potential issue with the closed stopcock and non-vented cap configuration. During the sterilization process, this design 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, meaning the devices may not be sterile.
Healthcare facilities and consumers should stop using the affected tubing sets immediately. Users should contact Maquet Cardiovascular, LLC for instructions on returning the products or obtaining replacements. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Cardiovascular
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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