Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.
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, and the failure to assure sterility in a device used for extracorporeal circulation poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall involves specific batch numbers: 3000045166, 3000050578, and 3000054620. The product is identified by the material code 701050647R01 and was 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. This issue means that the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially compromising the sterility of the device.
Healthcare facilities and consumers who have these specific tubing sets should stop using them immediately. Users should contact Maquet Cardiovascular, LLC for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01
- 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: 3000045166 3000050578 3000054620
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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