Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling 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 risk-of-harm product (sterile medical device) where the sterility assurance level cannot be guaranteed, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 custom tubing sets for extracorporeal circulation. The recall involves specific batch numbers: 3000053103, 3000066198, 3000071830, and 3000073677. The product was distributed nationwide.
The recall is due to a potential defect in the sterilization process. During sterilization, 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, meaning the product may not be sterile.
Healthcare facilities and users of these custom tubing sets should stop using the affected units immediately. Users should contact Maquet Cardiovascular for instructions on how to return or dispose of the recalled products. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 Material:701049440R01
- 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: 3000053103 3000066198 3000071830 3000073677
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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