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U.S. Department of Health and Human Services

Class 3 Device Recall LHB, Perishable Item Pack Type III

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  Class 3 Device Recall LHB, Perishable Item Pack Type III see related information
Date Initiated by Firm March 22, 2013
Date Posted April 10, 2013
Recall Status1 Terminated 3 on November 25, 2013
Recall Number Z-1091-2013
Recall Event ID 64776
Product Classification First Aid Kit with drug - Product Code LRR
Product LHB, Perishable Item Pack Type III. Kit number: 2114011-100.

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 227 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.
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