RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
FDA device recall Z-0745-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Rad-Source Technologies, Inc.
- Reason for recall
- The firm completed a cooling system retrofit to preclude overheating and failure.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MOT
- Quantity affected
- 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.
- Date initiated
- 2002-06-01
- Date posted
- 2004-07-20
- Date terminated
- 2012-05-03
- Location
- Boca Raton, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 (K974210) | Rad-Source, Inc. | 1998-03-30 |