| Date Initiated by Firm | November 17, 2022 |
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| Date Posted | May 01, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1473-2023 |
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| Recall Event ID |
92043 |
| Product Classification |
Uv lamp, germicidal - Product Code RHP
|
| Product | OttLite Rechargeable UVC Disinfecting Wand |
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| Code Information |
model: UV10002M |
| FEI Number |
1000132325
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Recalling Firm/
Manufacturer |
Ottlite TEchnologies, Inc.
1715 N West Shore Blvd Ste 950
Tampa FL 33607-3920
|
| For Additional Information Contact | Louise Gardner
813-621-0058 |
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Manufacturer Reason
for Recall | Product allows for the emission of ultraviolet (UV) electronic product radiation in excess of exposure limits recommended by the International Commission on Non-ionizing Radiation Protection (ICNIRP). The emissions are hazardous to users and others in the vicinity. |
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FDA Determined
Cause 2 | Radiation Control for Health and Safety Act |
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| Action | OttLite, sent consumers a Notification letter. The letter identified the affected product, problem and actions to be taken. Consumers should immediately stop using the recalled product and return the item to OttLite to receive a replacement product. The letter provided instructions for returning your OttLite Rechargeable UVC Disinfecting Wand (model: UV10002M) to Ottlite.
1. Go to our website at: www.OttLite.com/Recall
2. Fill out the form at the website including letting us know if you still have the UV10002M UV Wand in your possession.
3. Copy your purchase receipt and submit it on the website form.
a. We will contact you and send a postage paid return envelope to return the wand if you still have it in your possession.
4. Once OttLite receives the consumer s information, we will ship a replacement Ottlite UVC Disinfecting Phone Case with Wireless Charging to the address you entered in the website. |
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| Quantity in Commerce | 7376 units |
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| Distribution | US Natioonwide Distribution |
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| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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