Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk
Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks 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 is classified as FDA Class II. The hazard involves a risk of incomplete washing of blood products, which is a significant safety concern for a medical device, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Haemonetics Corporation is recalling the CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device. The recall involves specific lots where the inner core of the bowl set may develop cracks. These cracks can result in leaks at the inner core, causing fluid to become trapped inside the bowl core.
The trapped fluid may trigger a long empty device error message and lead to the possibility of incomplete washing of the blood product. The device is intended for use to recover blood shed during or subsequent to an operation or trauma, process the blood by centrifugation and washing, and pump the processed red cell product for reinfusion into the patient.
The recall covers 42,739 units distributed worldwide and across all US states. Specific lots with bowl cracks are identified in the recall documentation, and the issue of missing instructions to check for cracks in the Instructions for Use (IFU) affects products manufactured between October 2014 and October 2019. Healthcare facilities should stop using the affected devices and contact Haemonetics for further instructions.
The recalled product
- Product
- CS Elite Fastpack, 225 mL, 150 Res 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, an
- Manufacturer
- Haemonetics Corporation
- Category
- Medical Device — Autotransfusion
- Hazard
- Affected units
- 42,739
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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