Maquet Getinge-BEQ-TOP 26402 ECC Pack Recall Due to Sterility Concerns
Maquet Cardiovascular is recalling specific batches of ECC Packs because a design feature 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 the hazard involves a potential failure of sterility assurance for a medical device used in extracorporeal circulation, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-TOP 26402 ECC Packs. The recall is due to a potential issue with the closed stopcock and non-vented cap configuration during the sterilization process. This configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the cap, meaning the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
The affected product is the Maquet Getinge-BEQ-TOP 26402 ECC Pack, Material 701062310. The recall covers the following batch numbers: 3000043296, 3000046809, 3000047251, 3000050480, 3000054805, 3000060727, and 3000066887. The product was distributed nationwide.
Healthcare facilities and consumers should check their inventory for these specific batch numbers. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. This 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 26402 ECC PACK Material: 701062310
- 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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