Agency classClass IIOur severity:High FDA (Drugs)·D-624-2013·Announced 2013-07-10

Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

Baxter Healthcare is recalling specific lots of 0.9% 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility failure in an IV drug) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Baxter Healthcare Corp. is recalling specific lots of 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container. The affected products are 50 mL and 100 mL units, identified by specific product codes and expiration dates of May 2013. The recall covers 845,520 units distributed nationwide and in Puerto Rico.

The recall was initiated due to a lack of assurance of sterility. A manufacturing issue occurred during the sealing of the closure assembly at the administration port, creating a potential for leakage. This defect could compromise the sterile integrity of the intravenous solution.

Healthcare providers and patients should stop using the affected lots immediately. The source text does not specify additional consumer actions or report any illnesses or injuries associated with the use of these products.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Baxter Healthcare Corp.
Category: Drug — Intravenous Solution
Hazard: sterility-failure
contamination
Affected units: 845,520

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 (6)

Lot #: a) Product code 2B0042: P285668
P285668A
P285668C
P285734
Exp 5/13
b) Product code 2B0043: P285395

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 · SODIUM CHLORIDE

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Same manufacturer · Baxter Healthcare Corp.

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Same hazard · sterility failure