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 is classified as FDA Class II. The hazard involves a potential failure to achieve sterility assurance, which poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 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 configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured.
The affected product is identified by the material number 709000430. The recall includes units with the following batch numbers: 3000060035, 3000065494, 3000067883, 3000071809, 3000074480, 3000075340, and 3000077550. The product was distributed nationwide.
Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions on returns or replacements. 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-T 9410 Lurie Chldns Small 1/4 Material: 709000430
- 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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