Date Initiated by Firm | August 07, 2003 |
Date Posted | August 26, 2003 |
Recall Status1 |
Terminated 3 on December 14, 2007 |
Recall Number | Z-0977-03 |
Recall Event ID |
27021 |
510(K)Number | K963391 |
Product Classification |
Source, Chemiluminescent Light - Product Code MPU
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Product | Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box. |
Code Information |
Lot numbers 24C06B, 24C06D, 24C06E, 24D04S. |
Recalling Firm/ Manufacturer |
Watson Diagnostics Inc. 311 Bonnie Circle Corona CA 92880
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For Additional Information Contact | Patsy Lilagan 909-493-5424 |
Manufacturer Reason for Recall | Lights split, spilling contents when bent to activate. |
FDA Determined Cause 2 | Other |
Action | Users are instructed to cease use and return the product immediately in a letter issued 8/7/2003 return receipt requested. |
Quantity in Commerce | 662 boxes |
Distribution | Nationwide. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = MPU
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