Maquet Getinge Priming Lines Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific priming lines for extracorporeal circulation 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 involves a medical device where sterility cannot be assured, creating a risk of harm (infection) that has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BO-T 41302 PRIMING LINES BUMC (Material: 701066291) used for extracorporeal circulation. The recall involves batch numbers 3000062472 and 3000071380, which 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, posing a potential risk of non-sterile components being used in medical procedures.
Healthcare facilities and distributors should stop using these specific priming lines and contact Maquet Cardiovascular for instructions on returning the affected units. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291
- 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: 3000062472 3000071380
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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