Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific batches of ECC tubing sets because a design feature may prevent sterilization gas from reaching all fluid paths.
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, 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-TOP 49103 ECC Pack 0 No Bladder tubing sets. 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 the flow of humidity or 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.
The affected products are distributed nationwide. The specific batch numbers involved in this recall are 3000043158, 3000045091, 3000046739, 3000050831, 3000062044, and 3000065548. The product material code is 709000058.
Healthcare facilities and users should check their inventory for these specific batch numbers. If the affected products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. The 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 49103 ECC Pack 0 No Bladder Material: 709000058
- 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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