medical Class II Updated 2020-02-05

Haemonetics Corporation recalls Japan DISP SET, 263J, 205J, 208 - Product Usage: its related

Recalled Product

Japan DISP SET, 263J, 205J, 208 - 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-SET 1. Specific Lots with Bowl Cracks (1382 Distributed) FP Lot number: 0718027-0119029-190124H2; 0718027-0119029-190125H1; 0718027-0818085-181030H1; 0718027-0818086-181030H1; 0718027-1018006-181224H1; 0718027-1018007-181224H1; 0718027-1018008-181225H1; 0718027-1018009-181226H1; 0718027-1118031-181226H1; 0718027-1118032-181226H1; 0718027-1118081-190124H1; 0718027-1118083-190124H2 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
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