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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 ReNusee related information
Date Initiated by FirmAugust 17, 2009
Date PostedNovember 10, 2009
Recall Status1 Terminated 3 on May 10, 2012
Recall NumberZ-0159-2010
Recall Event ID 52987
PMA NumberP860023 
Product Classification Contact Lens Solution - Product Code LPN
ProductBausch & 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 NY 14609-3547
For Additional Information ContactCustomer Service
888-828-9030
Manufacturer Reason
for Recall		During routine testing the product failed to meet shelf life specifications.
FDA Determined
Cause 2		Other
ActionConsignees 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 Commerce5,000 bottles
DistributionDistribution: Nationwide, Trinidad, St. Croix, St. Thomas, Aruba and Bermuda.
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.
PMA DatabasePMAs with Product Code = LPN
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