Maquet Custom Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths.
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 source text explicitly identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving medical devices where sterility assurance is compromised.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall involves specific batch numbers: 3000065552, 3000070971, 3000074623, 3000076634, and 3000080868. The product is identified as Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287.
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 design issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured during the sterilization process.
The recall is classified as Class II by the FDA. The distribution pattern is listed as nationwide. Healthcare facilities and consumers should stop using these specific tubing sets and contact Maquet Cardiovascular for further instructions or replacement.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287
- Manufacturer
- Maquet Cardiovascular, LLC
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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