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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb ReNu MultiPurpose Solution, Equate MultiPurpose Solution and Target Brand MultiPur

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  Class 2 Device Recall Bausch & Lomb ReNu MultiPurpose Solution, Equate MultiPurpose Solution and Target Brand MultiPur see related information
Date Initiated by Firm March 05, 2007
Date Posted April 04, 2007
Recall Status1 Terminated 3 on January 09, 2008
Recall Number Z-0715-2007
Recall Event ID 37507
510(K)Number K020802  
Product Classification contact lens solution - Product Code LYL
Product Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu¿ Multi-Plus Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product is distributed in up to three sizes: 4 fl.oz., 12 fl. oz. and 16 fl. oz
Code Information Lot numbers appearing on the bottles distributed in the U.S.: GC6030, GC6037, GC6045, GC6061, GC6063, GC6072, GC6073 and GC6085. The lots all carry the expiration date ''2008-03'' on the bottle.   Lot numbers appearing on bottles distributed only outside of the U.S.: GC6038, GC6048 and GC6052.
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Customer Service
800-828-9030
Manufacturer Reason
for Recall		 A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.
FDA Determined
Cause 2		 Other
Action The firm issued a press release on 03/05/2006. Consignees were notified on 03/06/2007 via a customized Recall Notification Package via overnight courier with tracking and delivery confirmation capability. Bausch & Lomb Sales Representatives will visit the home offices of the major wholesale and distributors concurrent with the mailing of the notification packages.
Quantity in Commerce 1.5 million units
Distribution Worldwide, including USA, Argentina, Brazil, Canada, Chile, Costa Rica, Korea, Mexico, Taiwan and Venezuela.
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 = LYL and Original Applicant = BAUSCH & LOMB INCORPORATED
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