Agency classClass IIOur severity:Severe FDA (Drugs)·D-608-2013·Announced 2013-06-26

Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

Hospira is recalling 676,872 containers of 0.9% Sodium Chloride Injection due to a potential leak at the administrative port that compromises 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 injectable product, which poses a significant risk of infection or serious injury.

Plain-English summary

Hospira Inc. is recalling 676,872 containers of 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container. The product is identified by NDC 0409-7983-02 and Lot # 16-031-JT*, with an expiration date of April 1, 2014. The asterisk in the lot number may be followed by 01 or 02.

The recall was initiated because the product has the potential for solution to leak at or near the administrative port of the primary container. This defect creates a lack of assurance of sterility for the affected units.

The affected product was distributed nationwide and in Puerto Rico. Healthcare providers and facilities should stop using the recalled product and contact Hospira for further instructions.

The recalled product

Product: 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
Manufacturer: Hospira Inc.
Category: Drug — IV Fluids
Hazard: sterility
leakage
Affected units: 676,872

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 (3)

Lot #: 16-031-JT*
Exp 1APR2014
Note the * may be followed by 01 or 02

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Hospira Inc.

See all →

Critical
Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
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