Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1810-2014Class II

Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The...

Walmart Inc. / initiated 2014-02-26 / Terminated / root cause: manufacturing process

Wal Mart Stores, Inc began a recall of 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... on . FDA classified it as Class II and gives the reason as "Fifteen pairs of prescription, safety glasses did not meet required, industrial lens thickness; nor did these glasses have the OSHA-required manufacturer markings". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1810-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Walmart Inc.
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
Product code
HQG Lens, Spectacle, Non-Custom (Prescription)
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.
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1810-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1810-2014Class IITerminatedVoluntary: Firm initiated