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U.S. Department of Health and Human Services

Class 2 Device Recall BolXII

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  Class 2 Device Recall BolXII see related information
Date Initiated by Firm June 26, 2009
Date Posted September 22, 2009
Recall Status1 Terminated 3 on September 29, 2009
Recall Number Z-2236-2009
Recall Event ID 53041
510(K)Number K811528  
Product Classification bolus pad - Product Code JAD
Product Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy.
Code Information I1PSX-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 2		 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 and Original Applicant = ACTION PRODUCTS, INC.
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