Class 2 Device Recall Equate

• Date Initiated by Firm: September 25, 2014
• Date Posted: October 24, 2014
• Recall Status: Terminated on June 12, 2015
• Recall Number: Z-0126-2015
• Recall Event ID: 69347
• 510(K)Number: K083757
• Product Classification: Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
• Product: Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc.
• Code Information: Lot number: GBD14070 (twin packs), SKU: 630308
• Recalling Firm/ Manufacturer: Bausch & Lomb Inc- Greenville Solutions Plant; 8507 Pelham Rd; Greenville SC 29615-5749
• For Additional Information Contact: Robert H. Koger, IV; 864-281-2505
• Manufacturer Reason for Recall: Product lot did not meet the specification for its disinfectants at the time of manufacture.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter starting 09/25/2014.
• Quantity in Commerce: 18,792 bottles (9,396 twin packs)
• Distribution: US Nationwide Distribution in states of: AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MS, NC, NH, NY, OH, OR, PA, TN, TX, UT, VA, and WI.
• 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 = LYL and Original Applicant = BAUSCH & LOMB, INC.