Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific ECC 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 (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Custom Tubing Sets for Extracorporeal Circulation. The recall affects units with Batch Number 3000078425, 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. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the devices may not be sterile.
Healthcare facilities should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on return or replacement. Consumers are not directly affected as these are medical devices used in clinical settings.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material:701047962R01
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Cardiovascular
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: 3000078425
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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