Honeywell Issues Voluntary Nationwide Recall Of One Lot Of Eyesaline Eyewash Solution Due To Microbial Contamination
- Company Announcement Date:
- August 19, 2016
- FDA Publish Date:
- April 05, 2019
- Reason for Announcement:
Recall ReasonDevice & Drug Safety
- Company Name:
- Brand Name:
- Product Description:
Product DescriptionEyesaline Eyewash solution
In cooperation with the U.S. Food and Drug Administration (FDA), 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 we have not found any contamination in our batch testing, the voluntary recall is a precautionary measure due to a low 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.
Eyesaline Eyewash is sold through industrial sales distributors. 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.
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. See instructions below on how to find the lot number to determine if your supply is covered by this voluntary recall.
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.
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, shown at left, and on individual bottles, as shown on the right below.
Customers with questions regarding this recall can contact their distributor or Honeywell Customer Care at 1-800-430-5490, Monday – Friday, and 8:00 am – 6:30 pm EST. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to 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.
ConsumersHoneywell Customer Care