Honeywell Safety Products USA, Inc. Issues Voluntary Worldwide Recall of Honeywell Fendall 2000 Non-Sterile Eyewash Cartridges # 32-002050-0000 used with the Fendall 2000 Eyewash Station Due to a Lack of Appropriate Policies and Procedures by Honeywell’s Supplier

Summary

Company Announcement Date:
April 04, 2024

FDA Publish Date:
April 05, 2024

Product Type:
Drugs

Reason for Announcement:

Recall Reason Description
Non-compliance with current good manufacturing practice (cGMP) requirements.

Company Name:
Honeywell Safety Products USA

Brand Name:

Product Description:

Product Description

Non-Sterile Eyewash Cartridge

Company Announcement

FOR IMMEDIATE RELEASE – April 4, 2024 – Charlotte, NC, Honeywell Safety Products USA, Inc. is voluntarily recalling Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station. This recall is being conducted at the industrial consumer level. Honeywell’s supplier of the Fendall 2000 Non-Sterile Eyewash Cartridge has been found to be non-compliant with current good manufacturing practice (cGMP) requirements.

Risk Statement: Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such bacterial keratitis or endophthalmitis. Immunocompromised individuals, those sustaining ocular injuries that damage the corneal epithelium, and those sustaining penetrating ocular injuries are at higher risk of potential infection. To date, Honeywell Safety Products USA, Inc. has not received any reports of adverse events related to this recall.

The Fendall 2000 Non-Sterile Eyewash Cartridge is used for flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination. Product is contained in a 25-liter Ethylene-vinyl acetate (EVA) bag that is designed for use with the Fendall 2000 Eyewash Station. Only the Fendall 2000 refill cartridges are subject to this review, no other eyewash products. The saline eyewash solution contains purified water, benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate diabasic, and sodium phosphate monobasic. It is not marketed as sterile.

Product and Distribution Information Table
Product Name
Manufacturer’sProduct Number/ Catalog Number
Manufacturing Dates(DD/MMM/YYYY)
Expiration Date(DD/MMM/YYYY)
Region
Quantity
Fendall 2000 Non-Sterile Eyewash Cartridge
32-002050-0000
11-Oct- 2021 through 21-Jun-2023
11-Oct-2023 through 21-Jun-2025
USA
6,954
Fendall 2000 Non-Sterile Eyewash Cartridge
32-002050-0000
11-Oct- 2021 through 21-Jun-2023
11-Oct-2023 through 21-Jun-2025
Canada
3,651

Honeywell Safety Products USA, Inc. is notifying its distributors and customers by email, telephone or certified mail and is requesting anyone with product in its inventory to destroy or dispose of all units subject to the recall. Customers / distributors / retailers that have Fendall 2000 Non-Sterile Eyewash Cartridges should stop selling, shipping, and using the product immediately and destroy or dispose of it.

Customers with questions regarding this recall can contact Honeywell Safety Products USA, Inc. by telephone USA 1-800-430-5490, Canada 1-888-212-7233 or CustomerServiceInquiryBox@Honeywell.com between the hours of 8:00AM to 4:00PM EST. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this eyewash solution.

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.

 

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

Company Contact Information

 

Content current as of:
04/05/2024