May 2020 FDA Recall Drug by Icu Medical Inc
D-1270-2020 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Icu Medical Inc on May 8, 2020 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1270-2020

Reason for Recall
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Initiated
05-08-2020
Reported
05-27-2020
Quantity
93,648 flexible container

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85625
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-10-2021
Product Description About Product Description
Full technical description of the product.
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09

Batch or Lot Expiration Information

Lot# : 07-514-FW Exp. 01-JUL-2021