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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 Recall
Bausch & Lomb ReNu
see related information
Date Posted November 10, 2009
Recall Status1 Terminated on May 10, 2012
Recall Number Z-0159-2010
Recall Event ID 52987
Premarket Approval
PMA Number
P860023
Product Classification Accessories, Soft Lens Products - 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/
Manufacturer
Bausch & Lomb Inc
1400 North Goodman Street
Rochester, New York 14609-3547
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Customer Service
888-828-9030
Manufacturer Reason
for Recall
During routine testing the product failed to meet shelf life specifications.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LPN and Applicant = BAUSCH & LOMB, INC.
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