Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation 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 is classified as FDA Class II and involves a risk of harm (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P custom tubing sets used for extracorporeal circulation. The recall is due to a potential issue with the closed stopcock and non-vented cap configuration. During the sterilization process, this configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
The affected products are identified by batch numbers 3000044415, 3000046393, and 3000046736. The recall is classified as Class II by the FDA. The distribution pattern is listed as nationwide. The source text does not specify the exact number of units affected or report any specific illnesses or injuries associated with the use of these devices.
Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions on returns or replacements. The recall is precautionary to ensure patient safety by addressing the potential lack of sterility assurance in the stopcock ports.
The recalled product
- Product
- Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P Material:701066366
- 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: 3000044415 3000046393 3000046736
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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