Maquet Getinge-BEQ-T 3502 LVAD Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific LVAD tubing sets 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 the hazard is a potential failure of sterility assurance, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm risks.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 3502 LVAD 1/4" Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall involves batch numbers 3000074095 and 3000082174. The product is 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, which poses a risk of non-sterile components being used in medical procedures.
Healthcare facilities and users of these specific tubing sets should stop using the affected units and contact Maquet Cardiovascular for further instructions on replacement or return.
The recalled product
- Product
- Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01
- 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: 3000074095 3000082174
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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