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U.S. Department of Health and Human Services

Class 2 Device Recall DVX Rage Frame Safety glasses

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  Class 2 Device Recall DVX Rage Frame Safety glasses see related information
Date Initiated by Firm February 26, 2014
Date Posted June 17, 2014
Recall Status1 Terminated 3 on January 08, 2015
Recall Number Z-1810-2014
Recall Event ID 67740
Product Classification Lens, spectacle, non-custom (prescription) - Product Code HQG
Product Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black.

Safety Eye wear
Code Information Serial Numbers: 00174-1030010,  01839-1257619,  01249-1 013988,  00036-1175608,  01052-1100006,  00359-1150914,  03283-1 055954,  00773-1 043248,  05385-1 051400,  00644-1151291,  02402-1 028575,  01903-1041038,  02294-1 024246,  03729-1 020577, 02937-1071566 
Recalling Firm/
Manufacturer		 Wal Mart Stores, Inc
702 SouthWest 8th St
Bentonville AR 72716
For Additional Information Contact Scott Pickering
479-277-0720
Manufacturer Reason
for Recall		 Fifteen pairs of prescription, safety glasses did not meet required, industrial lens thickness; nor did these glasses have the OSHA-required manufacturer markings.
FDA Determined
Cause 2		 Employee error
Action Wal-Mart sent an Urgent Medical Device Recall letter dated March 12, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the Customer/User: Do not use the eyewear in any situation where safety-impact lenses are required. Replacement eyewear has been manufactured and available for the patient to pick up at the vision center where the original eyewear was purchased. Type of Action by the Company: Walmart contacted all patients on February 27 and 28. Patients were notified that their eyewear was not made at safety thickness, and that the patient should not wear the eyewear in an environment where safety thickness lenses are needed. Walmart manufactured replacement orders for all affected patients. Should you have any questions regarding this notice please call (479)277-0720
Quantity in Commerce 15 safety glasses
Distribution US Distribution including the states of AR, AL, CA, FL, KS, LA, MN, NJ, NV,OH, TX, and SC.
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.
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