Maquet Getinge-T Sample Manifold Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Sample Manifolds because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 are assigned a severity score of 4 (Severe), particularly when involving potential sterility failures in medical devices used for extracorporeal circulation.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-T 22706 Sample Manifold (Material: 701054912). The recall involves Batch Number 3000055636, which 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. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured, meaning the device may not be sterile.
Healthcare facilities and users of these devices should stop using the affected Sample Manifolds and contact Maquet Cardiovascular for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912
- 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: 3000055636
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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