Maquet Getinge Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation 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 involves a risk-of-harm product (medical device) where sterility cannot be assured, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 5914 TCH 1/2 Inch Change Kits (Material: 709000334) used for extracorporeal circulation. The recall involves batch numbers 3000071200, 3000081154, and 3000084780, 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 sterilization. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially leaving the device non-sterile.
Healthcare facilities and users of these specific tubing sets should stop using the affected units and contact Maquet Cardiovascular for further instructions or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Maquet Getinge-BEQ-T 5914 TCH ¿ Inch Change Kit Material: 709000334
- 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: 3000071200 3000081154 3000084780
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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