March 2024 FDA Recall Fendall 2000 Pure Flow by Honeywell Inc
D-0461-2024 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Honeywell Inc on March 29, 2024 for the product Fendall 2000 Pure Flow. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0461-2024

Reason for Recall
CGMP Deviations
Initiated
03-29-2024
Reported
05-01-2024
Quantity
10, 605 cartridges

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94345
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
HONEYWELL INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA, Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-30-2024
Product Description About Product Description
Full technical description of the 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

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

0498-0631-37 Fendall 2000 Pure Flow