Multi-event October 2019 FDA Recall Drug by Icu Medical Inc

This Multi-event Class I drug recall was voluntarily initiated by Icu Medical Inc on October 25, 2019 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.

Reported Recall Events

D-0350-2020 TERMINATED D-0349-2020 TERMINATED

Recall Number: D-0350-2020

Reason for Recall
Presence of Particulate Matter.
Initiated
10-25-2019
Reported
11-13-2019
Quantity
58,464 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84144
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-20-2022
Product Description About Product Description
Full technical description of the product.
0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25

Batch or Lot Expiration Information

Lot# Lot: 95-101-C6 Exp. 01 MAY 2020

Recall Number: D-0349-2020

Reason for Recall
Presence of Particulate Matter.
Initiated
10-25-2019
Reported
11-13-2019
Quantity
389,808 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84144
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-20-2022
Product Description About Product Description
Full technical description of the product.
LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03

Batch or Lot Expiration Information

Lot# Lot: 84-603-FW Exp. 01 DEC 2019