Device product
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Z-1824-2012
Product summary
- Event
- Event 57878
- Status
- Terminated
- Classification
- Class II
- Quantity
- 133,150 vials
- Official record key
device-enforcement:Z-1824-2012
Official wording
Reason: CGMP Deviations: Incomplete documentation associated with test results.
Code information: Lot 406952 (Expiration Date 02/11)
Distribution pattern: Nationwide Distribution and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations