medical Class II Updated 2020-02-05

Haemonetics Corporation recalls CS5/5+ Fastpacks, 125 mL, 150¿ Res Autotransfusion Device -

Recalled 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.

Hazard / Issue

Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog number/FG Item Number: 00265-00 1. Specific Lots with Bowl Cracks (720 distributed) Lot numbers: 1812011HTT 1902006HTT 1902007HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
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