Recall Z-0745-04 ยท MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Rad-Source Technologies, Inc.
RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
| Date | Jul 20, 2004 (initiated Jun 1, 2002) |
| Status | Terminated |
| Reason | The firm completed a cooling system retrofit to preclude overheating and failure. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974210 | SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 Rad-Source, Inc., Mar 30, 1998 |