Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow.
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 involves a medical device where sterility cannot be assured, creating a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific lots of Maquet Getinge BEQ-TOP 32100 Adult Custom Packs. These products are custom tubing sets used for extracorporeal circulation (ECC). The recall involves batch numbers 3000077084 and 3000084911, with material code 701054438R01. The products were 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 the sterilization process. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the products may not be sterile.
Healthcare facilities and consumers who have these specific products should stop using them immediately. Users should contact Maquet Cardiovascular, LLC for instructions on how to return the products for a refund or replacement.
The recalled product
- Product
- Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01
- 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: 3000077084 3000084911
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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