RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
This recall has been terminated (originally issued July 20, 2004).
- Recall Initiated
- June 1, 2002
- Posted
- July 20, 2004
- Terminated
- May 3, 2012
- Recall Number
- Z-0745-04
- Quantity
- 20
- Official Source
- View on FDA website ↗
Reason for Recall
The firm completed a cooling system retrofit to preclude overheating and failure.
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.
Lot / Code Info
Serial numbers: 1002 through 1005, 1007 through 1009, 1011 through 1023.
Root Cause
Other
Action Taken
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.