The Recall Desk
CriticalFDA (Drugs)·D-0216-2017·Announced 2016-12-28

Honeywell Eyesaline Eyewash Recalled for Klebsiella Pneumoniae Contamination

Sperian Eye & Face Protection is recalling 9,744 bottles of Honeywell Eyesaline Eyewash Sterile Isotonic Solution due to non-sterility and contamination with Klebsiella pneumoniae.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Sperian Eye & Face Protection, Inc. is recalling 9,744 bottles of Honeywell Eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.). The recall is due to non-sterility and contamination with Klebsiella pneumoniae.

The affected product is identified by Lot number F16091-61 with an expiration date of 03/2019. Specific product codes include 32-000455-0000-H5, 32-000455-0036, 32-000461-0036, 32-000462-0000-H5, and 32-000462-0036.

The product was distributed nationwide and exported to Australia, Mexico, and the United Arab Emirates. Consumers should check their inventory for the specific lot and product codes listed and stop using the product if it matches the recall details.

The recalled product

Product
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
Affected units
9,744

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot number: F16091-61
  • exp 03/2019 Product Codes: 32-000455-0000-H5
  • 32-000455-0036
  • 32-000461-0036
  • 32-000462-0000-H5
  • 32-000462-0036

Distribution

Distributed nationwide across the United States.