D-0350-2020 Class I Terminated

Recalled by ICU Medical Inc — Lake Forest, IL

FDA drug recall D-0350-2020 was initiated by ICU Medical Inc on October 25, 2019 and is designated Class I. Reason for recall: Presence of Particulate Matter. The recall status is terminated (terminated January 20, 2022). Affected quantity: 58,464 bags.

Recall Details

Product Type
Drugs
Report Date
November 13, 2019
Initiation Date
October 25, 2019
Termination Date
January 20, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
58,464 bags

Product Description

0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25

Reason for Recall

Presence of Particulate Matter.

Distribution Pattern

Nationwide in the USA.

Code Information

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