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Medical Device Notification: 150mL Eight Bag Aliquot System with Piercing Pin and Needleless Syringe Adaptor-Charter Medical, Ltd.

DATE NOTIFICATION INITIATED:

June 10, 2005 - Distributor Notification
June 20, 2005 - Customer Notification

PRODUCT / LOT NUMBER:

150mL Eight Bag Aliquot System with Piercing Pin and Needleless Syringe Adaptor

Lot Number: 108779
Catalog Number: T2288

MANUFACTURER:

Charter Medical, Ltd. Winston-Salem, North Carolina

REASON:

Charter Medical, Ltd. has initiated a voluntary recall of transfer packs, lot 108779. The product label is missing relevant information including sterilization method, expiration date, "Rx only" symbol and the "Do Not Reuse" symbol. Consignees have been asked to contact the manufacturer to arrange for an on-site visit to correct the labeling.

 

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