Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination

AUDIENCE: Risk Manager, Emergency Medicine, Pharmacy

ISSUE: Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury. Although no injuries have been reported and no contamination was found in batch testing, there is a risk of product contamination with Klebsiella pneumoniae. Although found in the normal flora of the mouth and skin, if the contaminant were present in a bottle, there is a potential for it to result in infections that may be sight-threatening.

Approximately 9,700 32-ounce bottles with lot number F16091-61 are subject to recall. No other lot number of the product is subject to this recall.

BACKGROUND: Eyesaline Eyewash is sold through industrial sales distributors. The affected product and lot number can be identified as follows:

Product: 32 ounce Eyesaline Eyewash
Lot number: F16091-61 (no other lot number is subject to recall)
The lot number can be found on the outside of the product case, and on individual bottles. See thepress release for product photos.

RECOMMENDATION: All of Honeywell’s distributors who received this lot have been notified by phone, e-mail and certified mail, and have been instructed to notify their customers. Distributors must stop distribution of the affected product and return it to Honeywell for credit or replacement. Commercial-industrial users of the product should also check whether their Eyesaline Eyewash is subject to recall. If it is, customers should stop using the solution and contact their distributor for replacement or credit.

Healthcare professionals and patients 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: www.fda.gov/MedWatch/report
Download form 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

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm517484.htm