Haemonetics Recalls Cell Saver 5/5+ Fastpacks Due to Potential Bowl Cracks
Haemonetics is recalling Cell Saver 5/5+ Fastpacks because cracks in the bowl core may cause fluid trapping and incomplete 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 involves a high-risk medical device where a defect could lead to incomplete washing of blood products, posing a risk of harm, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Haemonetics Corporation is recalling 14,095 units of CS5/5+ Fastpacks, 125 mL, 150° Res Autotransfusion Devices. The recall covers specific lots with bowl cracks (1812011HTT, 1902006HTT, 1902007HTT) 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 could result in fluid being trapped inside the bowl core, causing a long empty device error message and the possibility of incomplete washing. The affected devices are intended for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
The products were distributed worldwide, including nationwide in the United States and in various international countries. Healthcare facilities and users should stop using the affected units and contact Haemonetics Corporation for further instructions.
The recalled product
- Product
- CS5/5+ Fastpacks, 125 mL, 150¿ 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
- Affected units
- 14,095
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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