| 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. |
| FEI Number |
1827505
|
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
|
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