Maquet Getinge Infant ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific infant extracorporeal circulation tubing sets because a design feature 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 the sterility assurance level cannot be guaranteed, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge BEQ-TOP 28901 MCV INFANT ECC tubing sets. The recall involves specific batch numbers: 3000046112, 3000051162, 3000056133, 3000062045, 3000071402, 3000074895, 3000075715, and 3000078940. The product 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 sterilization. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, creating a potential risk of non-sterile equipment.
Healthcare facilities and consumers should check their inventory for the affected batch numbers. If the product is found, it 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 beyond the identification of the defect.
The recalled product
- Product
- Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01
- 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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