FDA MedWatch – Honeywell Fendall 2000 Non-Sterile Eyewash Cartridges # 32-002050-0000 Used With the Fendall 2000 Eyewash Station by Honeywell Safety Products USA

TOPIC: Honeywell Fendall 2000 Non-Sterile Eyewash Cartridges # 32-002050-0000 Used with the Fendall 2000 Eyewash Station by Honeywell Safety Products USA: Recall – Due to a Lack of Appropriate Policies and Procedures by Honeywell’s Supplier

AUDIENCE: Consumer, Health Professional, Pharmacy, Ophthalmology

ISSUE: Honeywell Safety Products is recalling Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station because 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 has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: 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.

RECOMMENDATIONS: 

• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this eyewash solution.

• Consumers with questions regarding this recall can contact Honeywell Safety Products USA by telephone USA 1-800-430-5490, Canada 1-888-212-7233 or CustomerServiceInquiryBox@Honeywell.com.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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