Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific batches of custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow.
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 specific batches of Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Packs. The affected products are custom tubing sets used for extracorporeal circulation (ECC). The recall involves batch numbers 3000043613 and 3000076067, which were distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration on these devices may prevent the flow of humidity and ethylene oxide gas into the fluid path during the sterilization process. This design issue means that the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured, potentially compromising the sterility of the device.
Healthcare facilities and users of these specific tubing sets should stop using the affected batches immediately. Users should contact Maquet Cardiovascular, LLC for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115
- 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: 3000043613 3000076067
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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