Maquet Getinge Custom Neonatal ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific neonatal extracorporeal circulation tubing sets because a design feature may prevent proper sterilization gas flow, 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. The hazard involves a potential failure of sterilization assurance, which poses a risk of infection or harm, but the source text does not report any specific illnesses, injuries, or hospitalizations, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal (Material: 709000069R02). The recall affects specific batch numbers: 3000051158, 3000061507, 3000067518, and 3000069468. The product was distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration on the tubing sets 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) for the stopcock ports cannot be assured, meaning the sterility of the device is not guaranteed.
Healthcare facilities and consumers who have these specific products should stop using them immediately and contact Maquet Cardiovascular, LLC for instructions on return or replacement. 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 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02
- 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: 3000051158 3000061507 3000067518 3000069468
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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