Maquet Getinge ROTAFLOW Support Pack Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling ROTAFLOW Support Packs because a design feature may prevent sterilization gas from reaching all parts, potentially 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) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-T 49002 ROTAFLOW Support Packs (Material: 701067280). The recall involves batch number 3000044421, which were distributed nationwide.
The recall is due to a potential issue with the sterilization process. During sterilization, the closed stopcock and non-vented cap configuration may prevent humidity or ethylene oxide gas from flowing into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
These products are custom tubing sets used for extracorporeal circulation. Because the sterility of the device cannot be guaranteed, there is a risk that the product may not be sterile when used. Healthcare facilities should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280
- 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: 3000044421
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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