Recalls / Class II
Class IID-626-2013
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 name
- Heparin Sodium In Sodium Chloride
- Generic name
- Heparin Sodium
- Active ingredient
- Heparin Sodium
- Route
- Intravenous
- NDCs
- 0338-0424, 0338-0431, 0338-0433, 0338-0428
- FDA application
- NDA018609
- Affected lot / code info
- Lot #: a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13
Why it was recalled
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.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide & Puerto Rico
Timeline
- Recall initiated
- 2013-05-21
- FDA classified
- 2013-06-28
- Posted by FDA
- 2013-07-10
- Terminated
- 2015-06-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-626-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.