Class 2 Device Recall BolXII

• Date Initiated by Firm: June 26, 2009
• Date Posted: September 22, 2009
• Recall Status: Terminated on September 29, 2009
• Recall Number: Z-2237-2009
• Recall Event ID: 53041
• 510(K)Number: K811528
• Product Classification: bolus pad - Product Code JAD
• Product: Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy.
• Code Information: I1PIT-0000
• Recalling Firm/ Manufacturer: Action Products Incorporated; 954 Sweeney Dr; Hagerstown MD 21740-7111
• For Additional Information Contact: Mistie Witt; 301-797-1414 Ext. 1044
• Manufacturer 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.
• FDA Determined 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 in Commerce: 1 carton
• Distribution: Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAD