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Class 2 Device Recall Equate |
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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
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Product Classification |
Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
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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
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For Additional Information Contact |
Robert H. Koger, IV 864-281-2505
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Manufacturer Reason for Recall |
Product lot did not meet the specification for its disinfectants at the time of manufacture.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = LYL and Original Applicant = BAUSCH & LOMB, INC.
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