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 is classified as FDA Class II and involves a risk of non-sterile medical equipment (infection risk) where no specific injuries or illnesses have been 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) due to a potential sterility issue. The recall involves specific batch numbers 3000049556 and 3000067468, with material code 701050060. The products were distributed nationwide.
The recall is being issued 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, which poses a risk of non-sterile equipment being used in medical procedures.
Healthcare facilities and consumers who have these specific tubing sets should stop using them immediately and contact Maquet Cardiovascular for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060
- 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: 3000049556 3000067468
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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