Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

Recall of CS3000 Apheresis Kits-Fenwal, Inc.

DATE RECALL INITIATED:

June 21, 2007

PRODUCT / LOT NUMBER:

CS 3000 Apheresis Kits (All lot numbers starting with "N")
Product Codes: 4R2180T, 4R2210T
International Distribution: R4R2210T, R4R2230T

MANUFACTURER:

Fenwal, Inc.
Round Lake, IL

REASON:

Fenwal has become aware of two instances where the anticoagulant citrate dextrose (ACD) and saline lines were reversed in the assembly process. The reversed line connections may not be visually apparent in the monitor box, and could result in excessive ACD infusion and severe injury, including death, to the donor. Fenwal will contact its customers to arrange for product return.

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 06/28/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.