Class 3 Device Recall RAD SOURCE

• Date Initiated by Firm: June 01, 2002
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 03, 2012
• Recall Number: Z-0745-04
• Recall Event ID: 26998
• 510(K)Number: K974210
• Product Classification: Elisa, Trichinella Spiralis - Product Code MDT
• Product: RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
• Code Information: Serial numbers: 1002 through 1005, 1007 through 1009, 1011 through 1023.
• Recalling Firm/ Manufacturer: Rad-Source Technologies, Inc.; 20283 State Rd. 7; Suite 107; Boca Raton FL 33498
• For Additional Information Contact: Randy Kirk; 888-396-3339
• Manufacturer Reason for Recall: The firm completed a cooling system retrofit to preclude overheating and failure.
• FDA Determined Cause: Other
• Action: The firm e-mailed a notification on May 9, 2002 to its consignees giving them instructions on using additional radiation indictors to assure that the blood units were correctly irradiated. They also initiated a cooling tube retrofit of all units on that date and this was completed on 8/13/2002.
• Quantity in Commerce: 20
• Distribution: Units were distributed to 20 blood banks and transfusion services in WI, KS, IN, MI, GA, NC, WA, NE, FL, IN, TX, MD, Washington DC, SC, and NM.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MDT