Haemonetics Recalls Cell Saver 5/5+ and Elite Bowl Sets Due to Leak Risk
Haemonetics is recalling Cell Saver 5/5+ and Elite bowl sets because potential leaks may trap fluid, causing incomplete washing of recovered blood.
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, and the hazard involves a risk of incomplete washing of blood products, which poses a risk of harm even though no specific injuries are reported in the text.
Plain-English summary
Haemonetics Corporation is recalling specific Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. The recall involves 38,699 units distributed worldwide and across the United States. The affected products are intended for the recovery and processing of blood shed during or subsequent to an operation or trauma.
The recall is due to a 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 recovered blood. The recall includes a specific lot (118011) with bowl cracks and all products manufactured between October 2014 and October 2019 that are missing instructions to check for cracks in the Instructions for Use (IFU).
Healthcare facilities and users should stop using the affected bowl sets and contact Haemonetics Corporation for further instructions. The agency has classified this as a Class II recall.
The recalled product
- Product
- JAPAN LOW VOL(125ML) CS5 SET,LN 261J - 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. The recovered blood is processed by a centrifugation and was
- Manufacturer
- Haemonetics Corporation
- Hazard
- Affected units
- 38,699
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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