Device product
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Z-2012-2025
Product summary
- Event
- Event 97007
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,754 boxes (120,128 doses)
- Official record key
device-enforcement:Z-2012-2025
Official wording
Reason: Out of specification stability test result for the Caphosol B solution from process validation lots
Code information: UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
Distribution pattern: Worldwide - US Nationwide distribution in the states of GA, OH, TN, TX, VA and the countries of Germany, France, Italy, Portugal, Spain, Sweden, United Kingdom.
Derived failure modes
-
Potency or specification failure
Out of specification