Medications & Supplements/Prescription Drugs

ICU Medical Inc: Sodium Chloride and Dextrose Injections Recalled for Potential Sterility Risk

Agency Publication Date: June 20, 2018

Summary

ICU Medical Inc is recalling over 3 million bags of Hospira brand Sodium Chloride and Dextrose Injections because the bags may leak, which could lead to a loss of sterility. The recall affects 0.45% Sodium Chloride (100 mL), 0.9% Sodium Chloride (100 mL and 250 mL), and 5% Dextrose (250 mL) injections used in medical settings. If the sterility of these intravenous fluids is compromised, it could lead to serious infections in patients receiving the medication.

Risk

A leaking bag can allow bacteria and other contaminants to enter the fluid, compromising the sterility required for intravenous injections. This poses a risk of infection or systemic illness for any patient receiving the affected medication.

What You Should Do

Check your medical supplies for 0.45% Sodium Chloride Injection (NDC 0409-7730-37) with lot 85-023-JT (Exp 7/1/2019).
Check for 0.9% Sodium Chloride Injection (NDC 0409-7983-02) with lots 85-018-JT or 85-031-JT (Exp 01/01/2020).
Check for 0.9% Sodium Chloride Injection (NDC 0409-7984-23) with lot 85-016-JT (Exp 01/01/2020).
Check for 0.9% Sodium Chloride Injection (NDC 0409-7984-37) with lots 85-021-JT (Exp 01/01/2020) or 86-001-JT (Exp 02/01/2020).
Check for 5% Dextrose Injection (NDC 0409-7922-02) with lot 86-033-JT (Exp 08/01/2019).
If you identify any affected lots, stop using them immediately and contact your healthcare provider or pharmacist for guidance.
Contact the manufacturer, ICU Medical Inc, and return any unused product to the place of purchase for a refund.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: 0.45% Sodium Chloride Injection, USP, 100 mL bag, Hospira

Model:

NDC 0409-7730-37

Recall #: D-0881-2018

Lot Numbers:

85-023-JT (Exp 7/1/2019)

Date Ranges: 7/1/2019

Product: 0.9% Sodium Chloride Injection, USP, 250 mL bag, Hospira

Model:

NDC 0409-7983-02

Recall #: D-0882-2018

Lot Numbers:

85-018-JT (Exp 01/01/2020)

85-031-JT (Exp 01/01/2020)

Date Ranges: 01/01/2020

Product: 0.9% Sodium Chloride Injection, USP, 100 mL bag, Hospira

Model:

NDC 0409-7984-23

Recall #: D-0883-2018

Lot Numbers:

85-016-JT (Exp 01/01/2020)

Date Ranges: 01/01/2020

Product: 0.9% Sodium Chloride Injection, USP, 100 mL bag, Hospira

Model:

NDC 0409-7984-37

Recall #: D-0884-2018

Lot Numbers:

85-021-JT (Exp 01/01/2020)

86-001-JT (Exp 02/01/2020)

Date Ranges: 01/01/2020, 02/01/2020

Product: 5% Dextrose Injection, USP, 250 mL bag, Hospira

Model:

NDC 0409-7922-02

Recall #: D-0885-2018

Lot Numbers:

86-033-JT (Exp 08/01/2019)

Date Ranges: 08/01/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80213

Status: Resolved

Manufacturer: ICU Medical Inc

Sold By: Hospitals; Pharmacies; Medical clinics

Manufactured In: United States

Units Affected: 5 products (88960 bags; 941496 bags; 525984 bags; 1247200 bags; 267288 bags)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical supplies for 0.45% Sodium Chloride Injection (NDC 0409-7730-37) with lot 85-023-JT (Exp 7/1/2019).

Check for 0.9% Sodium Chloride Injection (NDC 0409-7983-02) with lots 85-018-JT or 85-031-JT (Exp 01/01/2020).

Check for 0.9% Sodium Chloride Injection (NDC 0409-7984-23) with lot 85-016-JT (Exp 01/01/2020).

Check for 0.9% Sodium Chloride Injection (NDC 0409-7984-37) with lots 85-021-JT (Exp 01/01/2020) or 86-001-JT (Exp 02/01/2020).

Check for 5% Dextrose Injection (NDC 0409-7922-02) with lot 86-033-JT (Exp 08/01/2019).

If you identify any affected lots, stop using them immediately and contact your healthcare provider or pharmacist for guidance.

Contact the manufacturer, ICU Medical Inc, and return any unused product to the place of purchase for a refund.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: 0.45% Sodium Chloride Injection, USP, 100 mL bag, Hospira

Model:

NDC 0409-7730-37

Recall #: D-0881-2018

Lot Numbers:

85-023-JT (Exp 7/1/2019)

Date Ranges: 7/1/2019

Product: 0.9% Sodium Chloride Injection, USP, 250 mL bag, Hospira

Model:

NDC 0409-7983-02

Recall #: D-0882-2018

Lot Numbers:

85-018-JT (Exp 01/01/2020)

85-031-JT (Exp 01/01/2020)

Date Ranges: 01/01/2020

Product: 0.9% Sodium Chloride Injection, USP, 100 mL bag, Hospira

Model:

NDC 0409-7984-23

Recall #: D-0883-2018

Lot Numbers:

85-016-JT (Exp 01/01/2020)

Date Ranges: 01/01/2020

Product: 0.9% Sodium Chloride Injection, USP, 100 mL bag, Hospira

Model:

NDC 0409-7984-37

Recall #: D-0884-2018

Lot Numbers:

85-021-JT (Exp 01/01/2020)

86-001-JT (Exp 02/01/2020)

Date Ranges: 01/01/2020, 02/01/2020

Product: 5% Dextrose Injection, USP, 250 mL bag, Hospira

Model:

NDC 0409-7922-02

Recall #: D-0885-2018

Lot Numbers:

86-033-JT (Exp 08/01/2019)

Date Ranges: 08/01/2019