medical Class II Updated 2020-02-05

Haemonetics Corporation recalls JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related

Recalled Product

JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

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: CSE-FP-225V-JA 1. Specific Lots with Bowl Cracks (1249 Distributed) FP Lot numbers: 1118017-0219057190124H10119084; 1118017-1118031181226H11118019; 1118017-1118031181226H11118063; 1118017-1118032181226H11118063; 1118017-1118081190124H10119084; 1118017-1118082190124H10119002; 1118017-1118082190124H20119002; 1118017-1118083190124H20119084 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
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