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COMPANY ANNOUNCEMENT

Honeywell Issues Voluntary Nationwide Recall Of One Lot Of Eyesaline Eyewash Solution Due To Microbial Contamination

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Honeywell Issues Voluntary Nationwide Recall Of One Lot Of Eyesaline Eyewash Solution Due To Microbial Contamination

Summary

Company Announcement Date:
August 19, 2016
FDA Publish Date:
April 05, 2019
Reason for Announcement:
Recall Reason
Device & Drug Safety
Company Name:
Honeywell
Brand Name:
Brand Name(s)
Honeywell
Product Description:
Product Description
Eyesaline Eyewash solution

Company Announcement

 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.

  • Case Label Showing Lot No. – EYESALINE EYEWASH, 32 oz., 12/cs. 
  • Bottle Label Showing Lot No. - EYESALINE EYEWASH, 32 oz. 

Consumers

Honeywell Customer Care
1-800-430-5490

Media

Don Galman
don.galman@honeywell.com
1(847)955-8389