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U.S. Department of Health and Human Services

Class 2 Device Recall MoiStir

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  Class 2 Device Recall MoiStir see related information
Date Initiated by Firm April 22, 2005
Date Posted May 11, 2005
Recall Status1 Terminated 3 on September 30, 2005
Recall Number Z-0820-05
Recall Event ID 31780
510(K)Number K851026  
Product Classification Saliva, Artificial - Product Code LFD
Product Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, CONTENTS: 3 fibre-tipped swabsticks premoistened with MOI-STIR mouth moistening solutioon and saliva supplement; Product Nos. 55299-703-03 and 55299-703-25. Distributed by Kingswood Laboratories, Inc., Indianapolis, IN 46256-3316. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 foil packs to the case.
Code Information Lots A2, 1193, 1209, 1233, 1260 and 1725.
Recalling Firm/
Manufacturer		 Kingswood Laboratories,Inc
10375 Hague Rd
Indianapolis IN 46256-3316
For Additional Information Contact Suchinda Stithit, R.Ph., Ph.D.
800-968-7772
Manufacturer Reason
for Recall		 Contaminated with Aspergillus and Penicillum molds.
FDA Determined
Cause 2		 Other
Action The firm issued a press release on 4/22/05 instructing consumers to not use the product and to return it to them. Consignees were notified via letter dated 4/22/05.
Quantity in Commerce 3026 cases
Distribution Nationwide.
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 = LFD and Original Applicant = KINGSWOOD LABORATORIES, INC.
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