Maquet Getinge Quadrox iD Pack Recall Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Quadrox iD Packs 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 medical device where sterility cannot be assured, posing a risk of infection (harm) without reported injuries, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge BEQ-TOP 27700 Quadrox iD Packs (Material: 701054389R02) with batch numbers 3000049066 and 3000053533. The recall is due to a potential issue with the closed stopcock and non-vented cap configuration during the sterilization process.
The agency notes that this configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which could compromise the sterility of the device.
The affected products were distributed nationwide. Healthcare facilities and users should stop using the affected units and contact the manufacturer for further instructions or replacement.
The recalled product
- Product
- Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02
- 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: 3000049066 3000053533
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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