Z-0745-04

RAD SOURCE RS 3000 Blood Irradiator Three Bag Option

Name: Z-0745-04 RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
Creator: Rad-Source Technologies, Inc.
Published: 2002-06-01
License: https://open.fda.gov/license/

Rad-Source Technologies, Inc. / initiated 2002-06-01 / Terminated

FDA source

Rad-Source Technologies, Inc. began a recall of RAD SOURCE RS 3000 Blood Irradiator Three Bag Option on 2002-06-01. The reason FDA records is "The firm completed a cooling system retrofit to preclude overheating and failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0745-04
Status: Terminated
Initiated: 2002-06-01
Posted: 2004-07-20
Terminated: 2012-05-03
Recalling firm: Rad-Source Technologies, Inc.
Product: RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
Product code: MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Reason for recall: The firm completed a cooling system retrofit to preclude overheating and failure.
FDA root 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.
Product codes and lots: Serial numbers: 1002 through 1005, 1007 through 1009, 1011 through 1023.

Product code MOT

K974210UnclassifiedShielded Cabinet X-Ray Radiation Source Device Model Rs 3000Rad-Source, Inc. / cleared 1998-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)