| Class 3 Device Recall LHB, Antiseptic Kit | |
Date Initiated by Firm | March 22, 2013 |
Date Posted | April 10, 2013 |
Recall Status1 |
Terminated 3 on November 25, 2013 |
Recall Number | Z-1087-2013 |
Recall Event ID |
64776 |
Product Classification |
First Aid Kit with drug - Product Code LRR
|
Product | LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305.
First Aid Kit. |
Code Information |
All kits shipped between 1/12010 through 3/4/2013. |
Recalling Firm/ Manufacturer |
Lighthouse For The Blind 10440 Trenton Ave Olivette MO 63132-1223
|
For Additional Information Contact | David Robson 314-423-4333 |
Manufacturer Reason for Recall | The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili |
FDA Determined Cause 2 | Labeling False and Misleading |
Action | The firm sent "URGENT DEVICE RECALL" letters dated March 22, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 800-542-3697 for questions regarding this notice. |
Quantity in Commerce | 2,815 kits |
Distribution | Nationwide Distribution including DC and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, KY, MI, MD, MN, MO, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA and WY. |
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.
|
|
|
|