Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation
Maquet Cardiovascular is recalling specific 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 risk-of-harm product (medical device) where sterility cannot be assured, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 custom tubing sets. The recall affects products with material number 701047962 and specific batch numbers including 3000047630, 3000050482, 3000055980, 3000060726, 3000066813, 3000068491, 3000070813, and 3000074323. These products were distributed nationwide.
The recall is due to a potential sterilization failure. During the sterilization process, 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. 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 devices should stop using the affected tubing sets 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-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Cardiovascular
- Hazard
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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