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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb ReNu

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  Class 2 Device Recall Bausch & Lomb ReNu see related information
Date Initiated by Firm August 17, 2009
Date Posted November 10, 2009
Recall Status1 Terminated 3 on May 10, 2012
Recall Number Z-0159-2010
Recall Event ID 52987
PMA Number P860023 
Product Classification Contact Lens Solution - Product Code LPN
Product Bausch & Lomb ReNu¿ Multi-Purpose Solution, 12 fl.oz. (355 ml), Bausch & Lomb, Incorporated, Rochester, NY 14609.

Product is used for For the cleaning, rinsing, disinfecting, and storage of soft contact lenses.
Code Information Lot Number GA8028.
Recalling Firm/
Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
During routine testing the product failed to meet shelf life specifications.
FDA Determined
Cause 2
Action Consignees were notified by letter on/about August 17, 2009. All consignees were asked to review their inventory and return any of the affected product to Stericycle Pharmaceutical Services. For questions about the recall process or need additional shipping labels, please contact Stericycle Inc. at 1-888-345-83 16. For questions regarding this recall, please contact Bausch & Lomb's Customer Resource Center at 1-800-828-6974.
Quantity in Commerce 5,000 bottles
Distribution Distribution: Nationwide, Trinidad, St. Croix, St. Thomas, Aruba and Bermuda.
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.
PMA Database PMAs with Product Code = LPN and Original Applicant = Bausch & Lomb, Inc.