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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies this as an FDA Class II recall. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential sterility failures in medical devices.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific custom tubing sets for extracorporeal circulation (ECC) under FDA recall number Z-1633-2019. The affected product is the Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8, with material number 701049440R02. The recall involves batch number 3000076147 and was 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 the sterilization process. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the devices may not be fully sterile.
Healthcare facilities and users of these specific tubing sets should stop using the affected units and contact Maquet Cardiovascular, LLC for instructions on return or replacement. This recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02
- 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: 3000076147
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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