Agency classClass IIOur severity:Severe FDA (Drugs)·D-626-2013·Announced 2013-07-10

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: sterility
contamination

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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same brand · HEPARIN SODIUM IN SODIUM CHLORIDE

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Same manufacturer · Baxter Healthcare Corp.

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Same hazard · sterility