Recalls / Class II
Class IID-0461-2024
Product
Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37
- Brand name
- Fendall 2000 Pure Flow
- Generic name
- Purified Water
- Active ingredient
- Water
- Route
- Ophthalmic
- NDC
- 0498-0631
- FDA application
- M018
- Affected lot / code info
- Manufacturer's Product Number/ Catalog Number: 32-002050-0000; Exp 06/21/2025
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- HONEYWELL INC
- Manufacturer
- Honeywell Safety Products USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 855 S Mint St, N/A, Charlotte, North Carolina 28202
Distribution
- Quantity
- 10, 605 cartridges
- Distribution pattern
- Nationwide USA, Canada
Timeline
- Recall initiated
- 2024-03-29
- FDA classified
- 2024-04-23
- Posted by FDA
- 2024-05-01
- Terminated
- 2024-09-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0461-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.