March 2021 FDA Recall Sodium Chloride by Icu Medical Inc
D-0313-2021 - Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use

This Class II drug recall was voluntarily initiated by Icu Medical Inc on March 9, 2021 for the product Sodium Chloride. The FDA reported the reason for recall as presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0313-2021

Reason for Recall
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Initiated
03-09-2021
Reported
03-31-2021
Quantity
425,628 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87484
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.
ICU Medical 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.
Distributed Nationwide in the USA to include Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2022
Product Description About Product Description
Full technical description of the product.
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09

Batch or Lot Expiration Information

Lot# Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023

Affected Packages Involved in this Recall

0990-7138-09 Sodium Chloride
0990-7138-36 Sodium Chloride
0990-6138-22 Sodium Chloride
0990-6138-03 Sodium Chloride
0990-7972-05 Sodium Chloride
0990-7972-07 Sodium Chloride