Maquet Getinge Small Patient ECC Pack Recall for Sterility Assurance Issues
Maquet Cardiovascular is recalling Small Patient ECC Packs because a design flaw may prevent proper sterilization, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge BEQ-TOP 24100 Small Patient ECC Pack (Material: 701050175R02). The recall involves specific batch numbers: 3000041467, 3000050581, 3000055641, 3000060358, 3000067467, 3000073974, and 3000083165. The product was distributed nationwide.
The recall is due to a potential defect in 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.
Healthcare facilities and users of these custom tubing sets for extracorporeal circulation should stop using the affected units. Users should contact Maquet Cardiovascular, LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02
- 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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