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U.S. Department of Health and Human Services

Class 2 Device Recall CVS Brand

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 Class 2 Device Recall CVS Brandsee related information
Date Initiated by FirmNovember 20, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on April 06, 2004
Recall NumberZ-0379-04
Recall Event ID 28079
510(K)NumberK010559 
Product Classification Accessories, Solution, Ultrasonic Cleaners For Lenses - Product Code LYL
ProductCVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced in 30 days or less. Contains hydrogen peroxide as the disinfecting agent. 12 Fl. Oz (355 ML). [OTC] Item Number: 191648
Code Information All lot codes
FEI Number 1217081
Recalling Firm/
Manufacturer		 CVS
1 CVS Drive
Woonsocket RI 02895-6146
For Additional Information ContactScott A. MacLennan
401-770-5099
Manufacturer Reason
for Recall		Product label fails to provide adequate warning for use
FDA Determined
Cause 2		Other
ActionCVS issued a product recall on 11/19/03, from the Category Manager to Store Operations for the product to be removed from retail stores. The request listed Item # 191648, CVS One-Step Disinfecting Solution, 12 fl. oz., all lot #''s,.Individual pieces (bottles) would be returned through a third party, Carolina Logistics. An e-mail was also sent on 11/19/03 from the Quality Assurance Department to the nine CVS distribution centers requesting item # 191648 be removed from its pick line location as well as any other warehouse locations and be put on quality hold. Each distribution center was asked to return the amount of product on hand at that particular center to the quality assurance department. The product was removed from sale from the CVS.com website.
Quantity in Commerce19, 261 units
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 = LYL
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