Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw 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 involves a medical device where sterility cannot be assured, posing a risk of infection (risk-of-harm product). No specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall involves specific batch numbers 3000057630 and 3000083783, which 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 during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the devices may not be sterile.
Healthcare facilities and users of these specific tubing sets should stop using the affected batches immediately. Users should contact Maquet Cardiovascular for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899
- 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: 3000057630 3000083783
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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