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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmAugust 07, 2003
Date PostedAugust 26, 2003
Recall Status1 Terminated 3 on December 14, 2007
Recall NumberZ-0977-03
Recall Event ID 27021
510(K)NumberK963391 
Product Classification Source, Chemiluminescent Light - Product Code MPU
ProductPapsure, 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
For Additional Information ContactPatsy Lilagan
909-493-5424
Manufacturer Reason
for Recall
Lights split, spilling contents when bent to activate.
FDA Determined
Cause 2
Other
ActionUsers are instructed to cease use and return the product immediately in a letter issued 8/7/2003 return receipt requested.
Quantity in Commerce662 boxes
DistributionNationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MPU
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