FDA Device

RAD SOURCE RS 3000 Blood Irradiator Three Bag Option

Hazard

The firm completed a cooling system retrofit to preclude overheating and failure.

What You Should Do

Remedy

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.

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Products

RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
Brand
Rad-Source Technologies, Inc. 20283 State Rd. 7 Suite 107 Boca Raton FL 33498
UPC
Serial numbers: 1002 through 1005, 1007 through 1009, 1011 through 1023.

Units Affected

20

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