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U.S. Department of Health and Human Services

Class 2 Device Recall Equate

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  Class 2 Device Recall Equate see related information
Date Initiated by Firm September 25, 2014
Date Posted October 24, 2014
Recall Status1 Terminated 3 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/
Bausch & Lomb Inc- Greenville Solutions Plant
8507 Pelham Rd
Greenville SC 29615-5749
For Additional Information Contact Robert H. Koger, IV
Manufacturer Reason
for Recall
Product lot did not meet the specification for its disinfectants at the time of manufacture.
FDA Determined
Cause 2
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.