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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Manufacturer
- Sperian Eye & Face Protection, Inc
- Category
- Drug — Ophthalmic Solution
- 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.
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