Maquet Getinge Rotaflow Pack Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling Rotaflow Packs because a design feature may prevent proper sterilization, 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 3/5 (High).
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 infection, but no injuries or illnesses have been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 57000 Rotaflow Packs (Material: 709000424) due to a potential sterility issue. The recall affects Batch Number 3000065091, which was distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from reaching the fluid path during sterilization. As a result, the Sterility Assurance Level (SAL) for the stopcock ports cannot be assured.
Healthcare facilities should stop using the affected Rotaflow Packs and contact Maquet Cardiovascular for further instructions on the recall process.
The recalled product
- Product
- Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424
- 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: 3000065091
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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