Haemonetics Recalls CS Elite Processing Sets Due to Potential Bowl Cracks
Haemonetics is recalling CS Elite Processing Sets (125 ml) because cracks in the bowl core may cause fluid trapping and incomplete blood 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, a risk-of-harm scenario where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Haemonetics Corporation is recalling the CS Elite Processing Set (125 ml) Autotransfusion Device. The recall involves specific lots where the bowl core may have cracks, as well as all products manufactured between October 2014 and October 2019 that are missing instructions to check for cracks in the Instructions for Use (IFU).
The identified defect is a potential to develop leaks at the inner core of the bowl sets. This condition 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.
The affected products were distributed worldwide, including nationwide distribution in the United States and in various countries in Asia, Europe, and Oceania. Users should stop using the affected devices and contact Haemonetics Corporation for further instructions.
The recalled product
- Product
- CS Elite Processing Set (125 ml) Autotransfusion Device - 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 p
- Manufacturer
- Haemonetics Corporation
- Category
- Medical Device — Autotransfusion
- Affected units
- 176,742
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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