Haemonetics Recalls Cell Saver Bowl Sets Due to Potential Leaks
Haemonetics is recalling Cell Saver bowl sets because cracks 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 harm (incomplete blood washing) in a medical device, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Haemonetics Corporation is recalling specific lots of Japan CS Elite FASTPACK DISP. SET - 125ML bowl sets. The recall involves 14,278 units distributed worldwide and across all 50 US states, DC, and several international countries.
The recall is due to a potential defect where the inner core of the bowl sets may develop leaks. This can 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 products are those with bowl cracks and those missing instructions to check for cracks in the Instructions for Use (IFU), manufactured between October 2014 and October 2019.
Healthcare facilities and users should stop using the affected bowl sets and contact Haemonetics Corporation for further instructions or a replacement.
The recalled product
- Product
- Japan CS Elite FASTPACK DISP. SET - 125ML - 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 pumping this p
- Manufacturer
- Haemonetics Corporation
- Hazard
- Affected units
- 14,278
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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