Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk
Haemonetics is recalling Cell Saver 5/5+ and Elite bowl sets because they may leak, trapping fluid and causing 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 functional defect (leaking) that could lead to incomplete washing of a medical device, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Haemonetics Corporation is recalling the High Speed Cell Saver 5/5+ Bowl Set Autotransfusion Device and related accessory components. The recall involves 3,563 units distributed worldwide, including in the United States and various international locations.
The recall was initiated because the bowl sets have the potential to develop leaks at the inner core. This defect can 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 device.
The affected products were manufactured between October 2014 and October 2019. The recall includes catalog number 0263A-00. Users should stop using the affected bowl sets and contact Haemonetics Corporation for further instructions.
The recalled product
- Product
- High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
- Manufacturer
- Haemonetics Corporation
- Hazard
- Affected units
- 3,563
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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