An industrial eyewash is being recalled as it does not meet manufacturing practice requirements and users run the risk of ocular infections.
The Fendall 2000 emergency eyewash station, specifically the internal cartridge, is manufactured by safety solutions company Honeywell, which announced a voluntary recall on Thursday. It informed the U.S. Food and Drug Administration (FDA), which published the recall notice on Friday.
The supplier of the Fendall 2000 Non-Sterile Eyewash Cartridge was found to be non-compliant with "current good manufacturing practice requirements." Honeywell has not received any notices about adverse reactions to the product.
"Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections," the recall notice read.
"Immunocompromised individuals, those sustaining ocular injuries that damage the corneal epithelium, and those sustaining penetrating ocular injuries are at higher risk of potential infection."
The saline eyewash solution is used to flush or irrigate the eye to lower the chances of severe injury caused by acids or particles that have entered the eye.
"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," said the recall statement.
Honeywell is specifically recalling the product's cartridges with the catalog number 32-002050-0000 and manufactured between the dates of October 11, 2021, and June 21, 2023, in the U.S. and Canada. The expiration dates run from October 11, 2023, through June 21, 2025.
The recall notice indicated that 6,954 cartridges in the U.S. and 3,651 in Canada were affected.
The recall applies only to its industrial customers and Honeywell has begun notifying its suppliers and clients by email about the recall. Honeywell's safety products are sold across five continents including, Africa, U.S., Europe, South America as well as Asia, according to its website.
Newsweek contacted Honeywell by email for comment.
Anyone who has experienced an adverse reaction to the product have been told to contact the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
Uncommon Knowledge
Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.
Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.
About the writer
Shannon Power is a Greek-Australian reporter, but now calls London home. They have worked as across three continents in print, ... Read more
To read how Newsweek uses AI as a newsroom tool, Click here.
