medical Class II Updated 2020-02-05

Haemonetics Corporation recalls CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device -

Recalled 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.

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: 00260-00 1. Specific Lots with Bowl Cracks (6920 Distributed) Lot numbers: 1907006HTT 1902005HTT 1902008HTT 1902011HTT 1906005HTT 1803013HTT 1804004HTT 1804006HTT 1804002HTT 1804009HTT 1805002HTT 1805003HTT 1811002HTT 1812010HTT 812011HTT 1901001HTT 1812005HTT 1812008HTT 1901007HTT 1808006HTT 1808010HTT 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
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