Haemonetics Recalls CS5/5+ Bowl Kits Due to Potential Leaks
Haemonetics is recalling CS5/5+ Bowl Kits because potential leaks may trap fluid, causing device errors and incomplete washing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 washing of blood processing equipment) where specific injury or illness has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Haemonetics Corporation is recalling the CS5/5+ Bowl Kit-125 mL Autotransfusion Device. The recall involves 333,443 units distributed worldwide and across all US states and DC. The product is intended for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
The recall is due to a potential for leaks at the inner core of the Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml 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.
Specific lots with bowl cracks include lot numbers 0119008, 0719045, 0819016, 1118051, 1118006, and 0919022. Additionally, all products manufactured between October 2014 and October 2019 are affected due to missing instructions to check for cracks in the Instructions for Use (IFU). Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- CS5/5+ Bowl Kit-125 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
- Affected units
- 333,443
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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