Agency classClass IIOur severity:Severe FDA (Drugs)·D-0282-2015·Announced 2014-12-03

Hospira Recalls 5% Dextrose and 0.9% Sodium Chloride Injection Bags

Hospira is recalling 340,272 bags of 5% Dextrose and 0.9% Sodium Chloride Injection due to potential punctures that may compromise sterility and cause leaks.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects (such as container integrity issues leading to sterility loss) are categorized as Severe (Score 4).

Plain-English summary

Hospira Inc. is recalling 340,272 bags of 5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL containers. The affected product is identified by NDC 0409-7941-09 and includes lots 32-104-JT (exp. 08/15), 34-136-JT (exp. 10/15), and 36-092-JT (exp. 12/15).

The recall was initiated due to a lack of assurance of sterility. Potential punctures through the overwrap and primary container may result in IV bag leaks, which could compromise the sterility of the solution. The product was distributed nationwide, as well as in Puerto Rico and the U.S. Virgin Islands.

Healthcare providers and patients should stop using the affected lots and contact Hospira Inc. for further instructions. The FDA has classified this recall as Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: 5% Dextrose and 0.9% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7941-09.
Manufacturer: Hospira Inc.
Category: Drug — IV Fluids
Hazard: sterility-compromise
container-integrity
Affected units: 340,272

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 # 32-104-JT
Exp. 08/15 Lot # 34-136-JT
Exp. 10/15 Lot # 36-092-JT
Exp. 12/15

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 11 recalled by Hospira Inc. 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 11 products in this recall →

Same manufacturer · Hospira Inc.

See all →

Critical
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FDA (Drugs) · 2017-05-31
Moderate
Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
Low
Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
Severe
Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
High
Hospira Symbiq Infusion Pump Recalled for White Screen Shutdown
FDA (Devices) · 2016-11-16

Same hazard · sterility compromise