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 involves a medical device defect that could lead to incomplete washing of blood products, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Haemonetics Corporation is recalling 1,092 units of the CS Elite Fastpack, 225 mL, 20° Res Autotransfusion Device. The recall covers specific lots with bowl cracks (1901003HTT and 1810008HTT) and all products manufactured between October 2014 and October 2019 that are missing instructions to check for cracks in the Instructions for Use (IFU).
The recall is due to a potential for leaks at the inner core of the device's bowl sets. This defect could result in fluid being trapped inside the bowl core, causing a long empty device error message and the possibility of incomplete washing of the blood product.
The affected devices were distributed worldwide, including nationwide in the United States and in various countries in Asia, Europe, and Oceania. The devices are intended for use in recovering and processing blood shed during or after surgery or trauma for reinfusion into the patient. Users should stop using the affected devices and contact Haemonetics Corporation for further instructions.
The recalled product
- Product
- CS Elite Fastpack, 225 mL, 20¿ 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
- Hazard
- Affected units
- 1,092
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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