Heparin Sodium and 0 — Class II drug recall D-626-2013
Terminated recall by Baxter Healthcare Corp., reported 2013-07-10, distributed nationwide. Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential admi
| Recall number | D-626-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2013-05-21 |
| Classified | 2013-06-28 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2015-06-18 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| NDC | 00338-0424, 00338-0424-18, 00338-0428, 00338-0428-12, 00338-0431, 00338-0431-03, 00338-0433, 00338-0433-04 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-626-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.