Maquet Getinge Neonate Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific neonate tubing sets because a design feature may prevent sterilization gas from reaching all parts of the device.
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-T 46200 3/16" x 1/4" Neonate Packs (Material: 701065620) used for extracorporeal circulation. The recall involves specific batch numbers: 3000043297, 3000045729, 3000046485, 3000049608, 3000052615, 3000054322, 3000056259, and 3000062050. 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, meaning the devices may not be fully sterile.
Healthcare facilities and consumers should stop using the affected tubing sets and contact Maquet Cardiovascular, LLC for further instructions or a replacement.
The recalled product
- Product
- Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620
- Manufacturer
- Maquet Cardiovascular, LLC
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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