Maquet Getinge Adult ECC Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, 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 infection (risk-of-harm product). No specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge BO-TOP 28903 Adult ECC Pack (Material: -709000093R01). The recall affects Custom Tubing Sets for Extracorporeal Circulation (ECC) with Batch Number 3000069722. The products 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 between the closed port and the cap during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which may compromise the sterility of the device.
Healthcare facilities and users should stop using the affected tubing sets immediately. Maquet Cardiovascular is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01
- 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: 3000069722
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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