FDA Medical Device Recalls (openFDA)
Rad-Source Technologies, Inc.: RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
- Recall number
- Z-0745-04
- Recalling firm
- Rad-Source Technologies, Inc.
- Product
- RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
- Status
- Terminated
- Initiated
- 2002-06-01
- Posted
- 2004-07-20
- Terminated
- 2012-05-03
- 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.
- Lot, serial or model codes
- Serial numbers: 1002 through 1005, 1007 through 1009, 1011 through 1023.
- 510(k) numbers
- ["K974210"]
- PMA numbers
- not on file
- Product code
- MOT
- Firm FEI
- 3002459090
- Firm city
- Boca Raton
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28