FDA recall D-1091-2017

ICU Medical Inc · Class II · drug

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

Reason for recall

Presence of Particulate Matter; stainless steel

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-07-26
Report date
2017-08-23
Termination date
2019-03-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1091-2017