medical Class II Updated 2020-02-05

Haemonetics Corporation recalls Japan DISP SET, 263J, 205J, HAR - Product Usage: its related

Recalled Product

Japan DISP SET, 263J, 205J, HAR - 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: 263J-SS-SET 1. Specific Lots with Bowl Cracks (110 Distributed) Lot number: 0718027-0119029-08170710119003; 0718027-0818086-08170711018045; 0718027-1118031-08170711118019; 0718027-1118081-08170710119084 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
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