Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk
Haemonetics is recalling 739 Cell Saver bowl sets because cracks in the inner core can 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 incomplete washing of blood products, which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Haemonetics Corporation is recalling 739 units of the JAPAN DISP SET, 261J, 205J, HAR (Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets). The recall was initiated because the inner core of these bowl sets has the potential to develop leaks. 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 recovered blood.
The affected products were distributed worldwide, including nationwide in the United States and in various countries in Asia, Europe, and Oceania. The specific lots affected include those with bowl cracks (17 distributed units) and all products manufactured between October 2014 and October 2019 that are missing instructions to check for cracks in the Instructions for Use (IFU). The catalog number for the affected items is 261J-SS-SET.
Healthcare facilities and users of these devices should stop using the affected bowl sets immediately. Users should contact Haemonetics Corporation for further instructions on how to return or dispose of the recalled products. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- JAPAN DISP SET, 261J, 205J, HAR - 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 washing
- Manufacturer
- Haemonetics Corporation
- Affected units
- 739
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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