FDA recall D-0062-2023

Product

0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Reason for recall

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2022-11-09

Report date

2022-11-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0062-2023