Haemonetics Recalls Cell Saver Elite Sets Due to Potential Bowl Leaks
Haemonetics is recalling Cell Saver Elite sets because potential leaks in the bowl core may cause fluid trapping and incomplete washing.
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 defect that could lead to incomplete washing of blood products, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Haemonetics Corporation is recalling the Japan Cell Saver Elite Set - 125ml. The recall involves 21,113 units manufactured between October 2014 and October 2019. These products were distributed worldwide, including in the United States and various international locations.
The recall was initiated due to a potential for leaks at the inner core of the Cell Saver Elite bowl sets. This defect could result in fluid being trapped inside the bowl core, which may cause a long empty device error message and the possibility of incomplete washing of the blood product.
Healthcare providers and facilities using these devices should stop using the affected units. The source text does not specify further consumer actions or report any illnesses or injuries associated with this defect.
The recalled product
- Product
- JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processe
- Manufacturer
- Haemonetics Corporation
- Hazard
- Affected units
- 21,113
Distribution
Part of a larger recall action
This product is one of 22 recalled by Haemonetics Corporation 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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