Device product
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, NDC 63323-545-05, Product Code 504505; Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.
Z-1825-2012
Product summary
- Event
- Event 57878
- Status
- Terminated
- Classification
- Class II
- Quantity
- Product Code 504501 (1 mL): 454,275 vials; Product Code 504505 (5 mL): 119,325 vials
- Official record key
device-enforcement:Z-1825-2012
Official wording
Reason: CGMP Deviations: Incomplete documentation associated with test results.
Code information: Product Code 504501 (1 mL): Lot 406912 (Expiration Date 01/11) and Lot 408072 (Expiration Date 09/11); Product Code 504505 (5 mL): Lot 406914 (Expiration Date 01/12)
Distribution pattern: Nationwide Distribution and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations