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Vaccines, Blood & Biologics

Medical Device Notification Transfer Set with 150 Micron Filter-Charter Medical

DATE NOTIFICATION INITIATED:

October 13, 2005

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Transfer Set with 150 micron filter with distal slip lock patient adapter
Lot Number: 110220
Catalog Number: 03-960-57
Expiration Date: June, 2009

MANUFACTURER:

Charter Medical, Ltd
Winston-Salem, NC 27103

REASON:

Charter Medical, Ltd. has initiated a voluntary recall of Lot 110220 (Transfer Set with 150 micron filter with distal slip lock patient adapter). The product is labeled sterile. However, the devices were not subjected to ethylene oxide sterilization processing and are therefore, non-sterile. Consignees have been asked to return any affected product to the manufacturer.

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: 06/26/2013
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