Elevated risk U.S. Food and Drug Administration

Fendall 2000 Non-Sterile Eyewash Cartridge recall: Non-compliance with current good manufacturing practice (cGMP) requirements

Recall published 2+ years ago

Non-compliance with current good manufacturing practice (cGMP) requirements.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: Risk Statement: Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such bacterial keratitis or endophthalmitis.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
April 4, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Fendall 2000
Product type
Prescription & OTC drugs

Products covered by this recall

Non-Sterile Eyewash Cartridge

What the company announced

FOR IMMEDIATE RELEASE – April 4, 2024 – Charlotte, NC, Honeywell Safety Products USA, Inc. is voluntarily recalling Fendall 2000 Non-Sterile Eyewash Cartridge for the Fendall 2000 Eyewash Station. This recall is being conducted at the industrial consumer level. Honeywell’s supplier of the Fendall 2000 Non-Sterile Eyewash Cartridge has been found to be non-compliant with current good manufacturing practice (cGMP) requirements.

Risk Statement: Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such bacterial keratitis or endophthalmitis. Immunocompromised individuals, those sustaining ocular injuries that damage the corneal epithelium, and those sustaining penetrating ocular injuries are at higher risk of potential infection. To date, Honeywell Safety Products USA, Inc. has not received any reports of adverse events related to this recall.

The Fendall 2000 Non-Sterile Eyewash Cartridge is used for flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination. Product is contained in a 25-liter Ethylene-vinyl acetate (EVA) bag that is designed for use with the Fendall 2000 Eyewash Station. Only the Fendall 2000 refill cartridges are subject to this review, no other eyewash products. The saline eyewash solution contains purified water, benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate diabasic, and sodium phosphate monobasic. It is not marketed as sterile.

  • Product and Distribution Information Table: Product Name · Manufacturer’s Product Number/ Catalog Number · Manufacturing Dates (DD/MMM/YYYY) · Expiration Date (DD/MMM/YYYY) · Region · Quantity
  • Product and Distribution Information Table: Fendall 2000 Non-Sterile Eyewash Cartridge · 32-002050-0000 · 11-Oct- 2021 through 21-Jun-2023 · 11-Oct-2023 through 21-Jun-2025 · USA · 6,954
  • Product and Distribution Information Table: Fendall 2000 Non-Sterile Eyewash Cartridge · 32-002050-0000 · 11-Oct- 2021 through 21-Jun-2023 · 11-Oct-2023 through 21-Jun-2025 · Canada · 3,651

Honeywell Safety Products USA, Inc. is notifying its distributors and customers by email, telephone or certified mail and is requesting anyone with product in its inventory to destroy or dispose of all units subject to the recall. Customers / distributors / retailers that have Fendall 2000 Non-Sterile Eyewash Cartridges should stop selling, shipping, and using the product immediately and destroy or dispose of it.

Customers with questions regarding this recall can contact Honeywell Safety Products USA, Inc. by telephone USA 1-800-430-5490, Canada 1-888-212-7233 or [email protected] between the hours of 8:00AM to 4:00PM EST. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this eyewash solution.

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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 25 liter

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Fendall 2000 — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  3. Report any infection or reaction you think the product caused to FDA MedWatch.
  4. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: Honeywell Safety Products USA, Inc. is notifying its distributors and customers by email, telephone or certified mail and is requesting anyone with product in its inventory to destroy or dispose of all units subject to the recall.

Company contact: Honeywell Safety Products USA — Consumers: Honeywell Safety Products USA, Inc., USA 1-800-430-5490, Canada 1-888-212-7233, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Fendall 2000 prescription & otc drugs recalled?

Non-compliance with current good manufacturing practice (cGMP) requirements. Risk Statement: Use of or exposure to the eyewash without seeking medical attention afterwards could result in a range of ocular infections such bacterial keratitis or endophthalmitis.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The notice says: Honeywell Safety Products USA, Inc. is notifying its distributors and customers by email, telephone or certified mail and is requesting anyone with product in its inventory to destroy or dispose of all units subject to the recall.

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