July 2017 FDA Recall Drug by Icu Medical Inc
D-1091-2017 - Presence of Particulate Matter; stainless steel

This Class II drug recall was voluntarily initiated by Icu Medical Inc on July 26, 2017 for the product Drug. The FDA reported the reason for recall as presence of particulate matter; stainless steel. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1091-2017

Reason for Recall
Presence of Particulate Matter; stainless steel
Initiated
07-26-2017
Reported
08-23-2017
Quantity
436,716 flexible containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77824
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-11-2019
Product Description About Product Description
Full technical description of the product.
0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09

Batch or Lot Expiration Information

Lot# Lot: 61-841-FW Exp. 01/01/2018