Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Recall for Sterility Assurance
Maquet Cardiovascular is recalling specific ECC pump 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 risk-of-harm product (medical device) where sterility cannot be assured, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC (Material: 701064867). The recall affects specific batch numbers: 3000045174, 3000049559, 3000057376, 3000063289, 3000069864, and 3000074097. The products were distributed nationwide.
The recall is due to a potential sterilization defect. During the sterilization process, the closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from flowing 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 should check their inventory for the affected batch numbers. If these products are found, they should be removed from service and returned to the manufacturer or disposed of according to local regulations. No specific instructions for end-users are provided in the source text, but the defect relates to the sterility of the device components.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867
- 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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