Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1884-2018Class II

Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser...

Santa Joy Ornament & Giftware Co / initiated 2017-11-21 / Terminated / root cause: manufacturing process

SANTA JOY ORNAMENT & GIFTWARE CO began a recall of Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns... on . FDA classified it as Class II and gives the reason as "It was discovered that the product units it imported may, at peak levels, emit radiation that exceeds the federal standard for Class IIIa products". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1884-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Santa Joy Ornament & Giftware Co
Product
Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.
Product code
RDZ Low-Power Laser Light Show Projector
Reason for recall
It was discovered that the product units it imported may, at peak levels, emit radiation that exceeds the federal standard for Class IIIa products.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
The Firm will bring the device into compliance by : 1. Santa Joy Ornament (SJO) will provide a full refund in exchange for the return of the models listed above. Returned products will be destroyed. 2. SJO has purchased optical measurement equipment and intends to measure the output of each laser product and ensure all laser products comply with applicable performance standards before shipment. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (410) 540-9840.
Quantity in commerce
433,128
Distribution
USA (nationwide) distribution
Product codes and lots
Model No: EZ-Illuminations Galaxy , EZ-Illuminations Northern Lights

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1884-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1884-2018Class IITerminatedFDA Mandated