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  4. ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP Due to the Presence of Particulate Matter
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COMPANY ANNOUNCEMENT

ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP Due to the Presence of Particulate Matter

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Animal & Veterinary
Drugs
Animal Drugs
Reason for Announcement:
Recall Reason Description
Presence of particulates (iron oxide)
Company Name:
ICU Medical Inc.
Brand Name:
Brand Name(s)
ICU Medical Inc.
Product Description:
Product Description
Lactated Ringer’s Injection, USP

Company Announcement

ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer's Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint.

Administration of a drug product that contains metal particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. To date, ICU Medical, Inc. has not received reports of adverse events related to this recall.

Lactated Ringer's Injection, USP is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient. Product was distributed nationwide both by ICU Medical direct to customers and through medical distributors. The product is for human and veterinary use.

The affected product lot, manufactured in the U.S. for ICU Medical by Hospira, a Pfizer company in July 2019 is listed below:


NDC Number

Product Description

Lot Number

Expiration Date

Configuration

Manufacture
Date

Distribution
Dates

0409-7953-09 Lactated
Ringer's
Injection, USP
07-514-FW 01-Jul-2021 1000 mL Flexible
Container
July 2019 September 2019
– October 2019

ICU Medical is notifying its distributors and customers of this recall by letter and is arranging for the return of all recalled products. Hospitals/distributors that have product that is being recalled should stop use/further distribution and return to place of purchase.

Customers with questions regarding this recall can call ICU Medical at 1-844-654-7780 Monday through Friday between the hours of 8 a.m. and 5 p.m. Central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
  • The Center for Veterinary Medicine recommends calling the drug company to report the adverse drug experience or product defect. The drug company responsible for the approved product(s) is required to submit reports of adverse drug experiences and product defects to FDA.
  • If you prefer to report directly to the FDA, you can submit FORM FDA 1932a,
  • "Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report". You can use this form to report adverse drug experiences for any animal drug (approved or not approved by FDA) or animal device. Unapproved animal drugs include compounded drug products.
  • Download the fillable 1932a electronic form and email the completed form to CVM1932a@fda.hhs.gov
  • If you have a question about ADE reporting or need a hard copy of the form, contact CVM by email at AskCVM@fda.hhs.gov, by phone at 1-888-FDA-VETS (1-888-332-8387)

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About ICU Medical, Inc.

ICU Medical, Inc. (Nasdaq: ICUI) is one of the world's leading pure-play infusion therapy companies with global operations and a wide-ranging product portfolio that includes IV solutions, IV smart pumps, dedicated and non-dedicated IV sets and needlefree connectors, along with pain management and safety software technology designed to help meet clinical, safety and workflow goals. In addition, the company manufactures automated pharmacy IV compounding systems with workflow technology, closed systems transfer devices for hazardous IV drugs, and cardiac monitoring systems to optimize patient fluid levels. ICU Medical is headquartered in San Clemente, California. On February 3, 2017, ICU Medical completed the acquisition of the Hospira Infusion Systems business from Pfizer.

More information about ICU Medical, Inc. can be found at www.icumed.com.

 


Company Contact Information

Consumers:
ICU Medical
1-844-654-7780
Media:
Tom McCall
949-366-4368
tmccall@icumed.com

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