Honeywell Safety Products USA, Inc., affiliated to conglomerate Honeywell International Inc., has recalled Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station, according to the U.S. Food and Drug Administration.
The recall was initiated due to a lack of appropriate policies and procedures by Honeywell’s supplier, which has been found to be non-compliant with current good manufacturing practice or cGMP requirements.
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.
The impacted product is contained in a 25-liter Ethylene-vinyl acetate or EVA bag that is designed for use with the Fendall 2000 Eyewash Station. 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.
The recall includes only the Fendall 2000 refill cartridges, and no other eyewash products.
The recall involves Fendall 2000 Non-Sterile Eyewash Cartridge sold in the USA with manufacturer’s product number/ catalog number of 32-002050-0000, manufacturing dates of 11-Oct- 2021 through 21-Jun-2023 and expiration date of 11-Oct-2023 through 21-Jun-2025.
About 6,954 units of the affected product were sold in the USA and about 3,651 units in Canada.
The agency noted that 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. However, Honeywell has not received any reports of adverse events related to the recall so far.
Consumers are urged to immediately destroy or dispose of all units subject to the recall.
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