Device product
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.
Z-1105-2025
Product summary
- Event
- Event 96076
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 89,312
- Official record key
device-enforcement:Z-1105-2025
Official wording
Reason: Due to nasal spray stability failure for bioburden.
Code information: NasoGel Spray UDI-DI/UPC code: 00705928045309 SKU / Lot Numbers: GSP30-2R-48-ENU-USL / NGS751 GSP30-0R-96-ENU-USL / NGS757 and NGS762 GSP30-ARA-INTL / NGS762 GSP30-SWE-INTL / NGS754 GSP30-ENG-INT / NGS755 GSP30-MAL-INTL / NGS756 GSP30-SPA-INT / NGS760 and NGS761
Distribution pattern: Worldwide - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, VA, VT, WA, and WI. The countries of Bahrain, Ireland, Malaysia, Mexico, and United Kingdom.
Derived failure modes
-
Potency or specification failure
stability failure