Fendall 2000 Pure Flow Liquid
FDA Recall NDC 0498-0631
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fendall 2000 Pure Flow (NDC 0498-0631). A significant event, classified as Class II, was initiated on Mar 29, 2024 by Honeywell Safety Products Usa, Inc.. The reported reason for this action was: "CGMP Deviations"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations
Mar 29, 2024
May 01, 2024
10, 605 cartridges
Recall Profile & Regulatory Data
Event ID
94345
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
HONEYWELL INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA, Canada
Termination Date
Sep 30, 2024
Product Description
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
Batch or Lot Expiration Information
Lot# Manufacturer's Product Number/ Catalog Number: 32-002050-0000; Exp 06/21/2025
Affected Packages Involved in this Recall
0498-0631-37Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
