Health product recall

NexSys PCS 300/ PCS2 Plasma Collection System

Last updated

Summary

Product
NexSys PCS 300/ PCS2 Plasma Collection System
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Industry

Affected products

Affected products

Lot or serial number

Model or catalog number

NexSys PCS 300 Plasma Collection System

All lots.

PCS-300-INT

PCS2

All lots.

06002-110-NA-EW
06002-CP-110
06002-110-EXP-EW
06002-CPL-110
06002-110-NA

Issue

A software defect is present where in the case that the customer is running on smart last cycle, and a procedure is aborted or has an unrecoverable interruption, the red blood cell loss estimation flag may not be accurate, and should not be used as the basis for donor deferral in the case of RBC loss.

Recall start date: July 15, 2022

Additional information

Details
Original published date: 2022-08-05
Alert / recall type
Health product recall
Category
Health product - Medical device - Gastroenterology & Urology
Health product - Medical device - Haematology
Companies

Haemonetics Corporation

125 Summer Street, Boston, Massachusetts, United States, 02110

Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-64417