Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser...
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1884-2018 | Class II | Terminated | FDA Mandated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
