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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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Partners located in the US (CA, FL, MA, MN) and Italy.