Maquet Pediatric CPB Packs Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling Pediatric CPB Packs because a design feature may prevent sterilization gas from reaching all fluid paths, 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 medical device where sterility cannot be assured, posing a risk of harm (infection) to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-T 4906 Pediatric CPB Pack (Material: 701056041). The recall involves Batch Number 3000041540, which was distributed nationwide.
The recall is due to a potential defect in the closed stopcock and non-vented cap configuration. During the sterilization process, this configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured.
These custom tubing sets are used for extracorporeal circulation. Because the sterility of the device cannot be guaranteed, there is a risk of introducing contaminants into the patient's bloodstream. Users should stop using the affected products and contact Maquet Cardiovascular for instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Cardiovascular
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: 3000041540
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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