Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific batches of Getinge-BEQ-TOP 32200 ECC Packs because a design feature may prevent proper sterilization of the stopcock ports.
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 the Sterility Assurance Level cannot be assured, creating a risk of harm (infection) without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 32200 ECC PACK (Material: 701053319). The affected products are Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall involves batch numbers 3000043054, 3000049462, 3000058326, 3000062722, 3000069369, and 3000073168. The products were distributed nationwide.
The recall was initiated because 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 during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which poses a risk of infection if the product is used in a clinical setting.
Healthcare facilities and distributors should check their inventory for the specific batch numbers listed above. If these products are found, they should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed by Maquet Cardiovascular, LLC.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319
- 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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