Baxter Healthcare Plasmapheresis System

Class: II
PRODUCT

Fenwal Autopheresis-C Plasmapheresis System, Models A-200, A-201, and A-
401. Recall #B-860-0.

REASON

The Autopheresis-C Plasmapheresis instruments with version 6.0 software
may proceed to “Saline Rinse” without displaying the Remove Plasma
prompt.

CODE

Product Code Numbers: 4R4550, 4R4560, 4R4561, R4R4585

MANUFACTURER

Baxter Healthcare Corporation, Largo, Florida.

SOFTWARE DEVELOPER

Baxter Healthcare Corporation, Round Lake, Illinois.

RECALLED BY

Baxter Healthcare Corporation, Deerfield, Illinois, by telephone and fax
dated May 5, 2000, followed by letter dated June 15, 2000. Firm-
initiated recall ongoing.

DISTRIBUTION

Nationwide and Canada.

QUANTITY

5,250 units were distributed