Drug product
Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015
D-626-2013
Product summary
- Event
- Event 65288
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-626-2013
Official wording
Reason: Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Code information: Lot #: a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13
Distribution pattern: Nationwide & Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility