Haemonetics Recalls Cell Saver 5/5+ Bowl Kits Due to Leak Risk
Haemonetics is recalling Cell Saver 5/5+ Bowl Kits 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 involves a medical device with a risk of incomplete washing due to leaks, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Haemonetics Corporation is recalling Cell Saver 5/5+ Bowl Kits (225 ml) autotransfusion devices. The recall involves specific lots where the bowl core may develop leaks, 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 hazard is that leaks at the inner core of the bowl sets could result in fluid being trapped inside the bowl core. This can cause a long empty device error message and the possibility of incomplete washing of the device.
The affected products were distributed worldwide, including nationwide in the United States and in various international countries. The source text does not specify the number of affected units or report any illnesses or injuries. Users should stop using the affected devices and contact the manufacturer for instructions.
The recalled product
- Product
- Cell Saver¿5/5+ Bowl Kit (225 ml) 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
- 690,043
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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