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U.S. Department of Health and Human Services

Class 2 Device Recall Bausch & Lomb Boston Conditioning Solution Original Formula

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  Class 2 Device Recall Bausch & Lomb Boston Conditioning Solution Original Formula see related information
Date Initiated by Firm June 30, 2009
Date Posted August 13, 2009
Recall Status1 Terminated 3 on May 10, 2012
Recall Number Z-1735-2009
Recall Event ID 52602
510(K)Number K983836  
Product Classification Accessories, soft lens products - Product Code LPN
Product Bausch & Lomb, Boston¿ Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Bausch & Lomb Incorporated, Rochester, NY 14609.
Code Information Lot Number: GA7060; Item Number: 7474G. Expires January 2009.
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 North Goodman Street
Rochester NY 14609-3547
For Additional Information Contact Doug Fortunato
585-338-6000
Manufacturer Reason
for Recall		 The product failed to meet one of the shelf life specifications at the end of the expiry period.
FDA Determined
Cause 2		 Other
Action Bausch & Lomb issued an "Urgent Voluntary Medical Device Recall" notice dated June 26, 2009. All consignees were requested to review their inventory, and return any of the affected product to Stericycle Pharmaceutical Services, Indianapolis, IN. A Business Reply Card was included to be returned to Bausch & Lomb via US mail. A prepaid UPS Packing Slip was also provided to return the affected product. For further questions, contact Bausch & Lomb Customer Resource Center at 1-800-828-9030.
Quantity in Commerce 56,000 bottles
Distribution Nationwide Distribution.
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 = LPN and Original Applicant = POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
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