Recall Z-2236-2009 ยท JAD System, Therapeutic, X-Ray
Action Products Incorporated
Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.
| Date | Sep 22, 2009 (initiated Jun 26, 2009) |
| Status | Terminated |
| Reason | Medical device intended for use by healthcare practitioners was incorrectly labeled. 1.0 cm thick pad was labeled as 0.5 cm thickness, and vice versa. |
| Root cause | Process control |
| Action | Action Products Inc. notified one affected distributor by phone and email on 06/26/09 and issued a Return Merchandise Authorization. |
| Quantity | 1 carton |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811528 | RADIATION BOLUS Action Products, Inc., Jul 10, 1981 |