Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation t
FDA device recall Z-2236-2009 · posted 2009-09-22 · Terminated
Recall details
- Recalling firm
- Action Products Incorporated
- Reason for recall
- 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.
- Action taken
- Action Products Inc. notified one affected distributor by phone and email on 06/26/09 and issued a Return Merchandise Authorization.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JAD
- Quantity affected
- 1 carton
- Distribution
- Nationwide distribution.
- Date initiated
- 2009-06-26
- Date posted
- 2009-09-22
- Date terminated
- 2009-09-29
- Location
- Hagerstown, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RADIATION BOLUS (K811528) | Action Products, Inc. | 1981-07-10 |