Recall StatusTerminated
Date Initiated2018-12-10
Date Terminated2023-05-02
Product Quantity250 devices of which 9 are affected
Reason for Recall
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Firm Action
ProSun initially notified customers on about 12/10/2018 via "URGENT: POTENTIAL UV EXPOSURE DISCREPANCY" letter. Instructions included to contact ProSun Customer Service at 727-825-0400 Ext 243 or 224 or by email at
[email protected] to coordinate receipt of a UV meter to verify UV output. Once received, customers should take the requested UV readings, fill out the form accompanying the UV meter, and return the UV meter with signed form via the enclosed return label. If there are any out-of-specification readings present, ProSun will contact that customer with a solution.
Another customer notification was sent to customers on about 3/11/19 via "URGENT: Urgent Recall Notice" letter. Instructions included were the same as the 12/10/18 letter.
Customers who were initially contacted via telephone call received a follow up letter with the same instructions.
If you have any questions, Contact ProSun Customer Service at 727-825-0400 Ext 224.
Distribution Pattern
US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.