MORRISTOWN (dpa-AFX) - 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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