Heparin Sodium Injection (Baxter) – sterility port leakage (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Baxter Healthcare Corp.
Lot Codes / Batch Numbers
Lot #: a) Product code 2B0944: N001164, Exp 7/13, b) Product code 2B0953: N001396, Exp 11/13
Products Sold
Lot #: a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13
Baxter Healthcare Corp. is recalling Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex P due to Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential f. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026