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, 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 involves a risk-of-harm product (medical device) where sterility cannot be assured, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific lots of Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack custom tubing sets. The recall is due to a potential defect in the sterilization process. The closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from reaching the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be guaranteed.
The affected product is distributed nationwide. The specific batch numbers involved in this recall are 3000048398, 3000075385, and 3000075472. These products are used for extracorporeal circulation (ECC) procedures.
Healthcare facilities and consumers should check their inventory for these specific batch numbers. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority for further instructions.
The recalled product
- Product
- Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack Material: 709000385
- 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: 3000048398 3000075385 3000075472
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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