medical Class II Updated 2020-02-05

Haemonetics Corporation recalls JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its re

Recalled Product

JAPAN LOW VOL(125ML) CS5 SET,LN 261J - 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. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit.


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: FG - 0261J-00 1. Specific Lot with Bowl Cracks (446 Distributed) Lot number: 118011 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
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