Maquet Getinge Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Getinge-BO-TOP tubing sets are being recalled because a design feature may prevent sterilization gas from reaching all parts, 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 (risk-of-harm product) without reported injuries or illnesses in the source text, which aligns with the 'High' severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BO-TOP 20705 Small Patient 1/4 Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall involves specific batch numbers: 3000080434 and 3000081004. The product was distributed nationwide.
The recall was initiated because the closed stopcock/non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
Healthcare facilities and users of these specific tubing sets should stop using the affected units and contact Maquet Cardiovascular, LLC for further instructions on the recall process.
The recalled product
- Product
- Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01
- 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: 3000080434 3000081004
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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