Haemonetics Recalls CS Elite Processing Sets Due to Potential Bowl Cracks
Haemonetics is recalling CS Elite Processing Sets because cracks 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 is classified as FDA Class II. The hazard involves a risk of incomplete washing of blood products, which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Haemonetics Corporation is recalling the CS Elite Processing Set (225 ml) Autotransfusion Device. The recall involves specific lots where the bowl core may have cracks, as well as products manufactured between October 2014 and October 2019 that are missing instructions to check for cracks in the Instructions for Use (IFU).
The identified hazard is the potential for leaks at the inner core of the 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.
The affected products were distributed worldwide and nationwide in the United States. The recall includes 37,248 units from specific lots with bowl cracks (Lot numbers: 0718008, 0818052, 0818110, 0119048, 0218064) and all products manufactured between October 2014 and October 2019 with the missing IFU instructions. Users should stop using the affected devices and contact Haemonetics Corporation for further instructions.
The recalled product
- Product
- CS Elite Processing Set (225 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
- Hazard
- Affected units
- 257,345
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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