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 parts of the device.
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, posing a risk of infection or harm, but the source text does not report any specific illnesses or injuries, 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 24105 ECC PACK custom tubing sets used 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 design 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 are identified by the following batch numbers: 3000051271, 3000057632, 3000062460, 3000066202, 3000069076, 3000073425, 3000076761, and 3000080703. The material code is 701064757. The distribution pattern is listed as nationwide.
Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular, LLC for further instructions on how to return or replace the products.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757
- 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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