Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the failure of a critical safety control (sterility) in a medical device used for extracorporeal circulation carries a high risk of serious harm (infection), aligning with the Severe category for Class II recalls with significant potential harm.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific custom tubing sets for extracorporeal circulation (ECC). The affected product is the Maquet Getinge BEQ-T 3501 LVAD 3/8" tubing, with material number 701068008R01 and batch number 3000074094. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is due to a potential sterilization failure. During the sterilization process, 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. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the product may not be sterile.
The affected units were distributed nationwide. Healthcare facilities and users of these specific tubing sets should stop using the affected batch and contact Maquet Cardiovascular for further instructions on replacement or return.
The recalled product
- Product
- Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01
- 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: 3000074094
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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