Haemonetics Recalls CS5/5+ Fastpacks Due to Potential Bowl Cracks
Haemonetics is recalling CS5/5+ Fastpacks because cracks in the bowl core may trap fluid, causing device errors 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 is classified as FDA Class II. The hazard involves a risk of harm (incomplete washing of a medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Haemonetics Corporation is recalling CS5/5+ Fastpacks, 225 mL, 150° Res Autotransfusion Devices. The recall involves 44,821 units distributed worldwide and across all US states. The specific issue involves potential cracks in the inner core of the bowl sets for Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml devices.
The cracks may result in fluid being trapped inside the bowl core. This condition can cause a 'long empty device' error message and the possibility of incomplete washing of the device. The recall covers 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).
Healthcare facilities and users should stop using the affected devices and contact Haemonetics Corporation for further instructions. The affected catalog number is 00260-00. Specific lot numbers with identified bowl cracks include 1907006HTT, 1902005HTT, 1902008HTT, 1902011HTT, 1906005HTT, 1803013HTT, 1804004HTT, 1804006HTT, 1804002HTT, 1804009HTT, 1805002HTT, 1805003HTT, 1811002HTT, 1812010HTT, 812011HTT, 1901001HTT, 1812005HTT, 1812008HTT, 1901007HTT, 1808006HTT, and 1808010HTT.
The recalled product
- Product
- CS5/5+ Fastpacks, 225 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
- 44,821
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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