Haemonetics Recalls Cell Saver Fastpacks Due to Potential Bowl Cracks
Haemonetics is recalling 8,641 Cell Saver 5/5+ Fastpacks because cracks in the bowl core can trap fluid, causing incomplete washing and device errors.
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, and the hazard involves a risk of harm (incomplete washing of a medical device) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Haemonetics Corporation is recalling 8,641 units of the CS5/5+ Fastpacks, 225 mL, 20° Res Autotransfusion Device. The recall involves specific lots 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).
The recall is due to a potential for leaks at the inner core of the bowl sets. 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 device.
The affected products were distributed worldwide, including nationwide in the United States and in various countries in Asia, Europe, and Oceania. Users of these medical devices should stop using the affected units and contact Haemonetics Corporation for further instructions.
The recalled product
- Product
- CS5/5+ Fastpacks, 225 mL, 20¿ Res 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
- Category
- Medical Device — Autotransfusion
- Affected units
- 8,641
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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