Maquet Getinge Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization of the stopcock ports.
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 the Sterility Assurance Level cannot be assured, creating a risk of harm from potential contamination, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 25502 1/4 Better Bladder tubing sets (Material: 709000434) used for extracorporeal circulation. The recall affects batch numbers 3000059445, 3000062029, 3000062476, and 3000080867, which were distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially compromising the sterility of the device.
Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions on replacement or return.
The recalled product
- Product
- Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434
- 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: 3000059445 3000062029 3000062476 3000080867
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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