Device product
Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer
Z-2054-2016
Product summary
- Event
- Event 73395
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,692 cartons
- Official record key
device-enforcement:Z-2054-2016
Official wording
Reason: Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Code information: Lot Number N4753A, Exp 11/16
Distribution pattern: Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV and Internationally to Canada.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility