D-626-2013 Class II Terminated
FDA drug recall D-626-2013 was initiated by Baxter Healthcare Corp. on May 21, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jun 18, 2015).
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 10, 2013
- Initiation Date
- May 21, 2013
- Termination Date
- Jun 18, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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.
Distribution Pattern
Nationwide & Puerto Rico
Code Information
Lot #: a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-626-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026