FDA Drug recall D-626-2013
Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-0…
- FDA Drug
- Class II
- terminated
- Published 2013-07-10
On 2013-07-10 the FDA classified a Class II recall of Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-0… by Baxter Healthcare, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-626-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-21 |
| Published | 2013-07-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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
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.
Identifiers
| ndc | 0338-0431-03 |
|---|---|
| ndc | 0338-0433-04 |
| ndc | 0338-0424-18 |
| ndc | 0338-0428-12 |
| code_info | Lot #: a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-626-2013%22
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