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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 Recall
Bausch & Lomb Boston Conditioning Solution Original Formula
see related information
Date Posted August 13, 2009
Recall Status1 Open
Recall Number Z-1735-2009
Recall Event ID 52602
Premarket Notification
510(K) Numbers
K923438  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, New York 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
EXPIRATION DATING: Incorrect or No Expiration Date
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 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.
510(K) Database 510(K)s with Product Code = LPN and Original Applicant = POLYMER TECHNOLOGY CORP.
510(K)s with Product Code = LPN and Original Applicant = POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
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