Baxter Recalls Heparin Sodium Injection Due to Sterility Concerns
Baxter Healthcare is recalling specific lots of Heparin Sodium in Sodium Chloride Injection due to a manufacturing defect that may compromise sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or infection.
Plain-English summary
Baxter Healthcare Corp. is recalling specific lots of Heparin Sodium in Sodium Chloride Injection. The recall is due to a manufacturing issue identified during the sealing of the closure assembly at the administration port, which has resulted in potential leakage and a lack of assurance of sterility.
The affected products are Heparin Sodium and 0.9% Sodium Chloride Injection in Viaflex Plus Containers. The specific lots involved are Product code 2B0944 (Lot N001164, Exp 7/13) and Product code 2B0953 (Lot N001396, Exp 11/13). These products were distributed nationwide and in Puerto Rico.
Healthcare providers and patients should check their inventory and medication records for these specific lot numbers. If these products are found, they should be stopped and returned to the supplier or the manufacturer for disposal.
The recalled product
- Product
- HEPARIN SODIUM IN SODIUM CHLORIDE (HEPARIN SODIUM)
- Brand
- HEPARIN SODIUM IN SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Anticoagulant
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: a) Product code 2B0944: N001164
- Exp 7/13
- b) Product code 2B0953: N001396
- Exp 11/13
Distribution
Part of a larger recall action
This product is one of 6 recalled by Baxter Healthcare Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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