• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmOctober 04, 2004
Date PostedOctober 28, 2004
Recall Status1 Terminated 3 on November 01, 2011
Recall NumberZ-0060-05
Recall Event ID 30216
Product Classification Accessories, Soft Lens Products - Product Code LPN
ProductSterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles. Sold under the following brand names: Family Dollar HomeBest HEB Meijer Food Lion health PRIDE Stop and Shop Super G sunmark Brite-Life Wegmans Our Family Healthy Generations GoodSense Winn Dixie Finast Western Family K C Pharmaceuticals
Code Information All Codes
Recalling Firm/
Manufacturer
K C Pharmaceuticals Inc
3220 Producer Way
Pomona CA 91768-3915
For Additional Information ContactSheila Solter
909-598-9499 Ext. 25
Manufacturer Reason
for Recall
Routine testing indicates product does not meet the expiration date in all cases.
FDA Determined
Cause 2
Other
ActionProduct is being recalled due to concern that the product does not meet it's expiration date. Firm sent letters to it customers requesting them to remove product from stores and to destroy it. A destruction form was sent with a request to mail it back.
Quantity in Commerce2,252,664
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.
-
-