FDA recall D-1270-2020

ICU Medical Inc · Class I · drug

Product

LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09

Reason for recall

Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2020-05-08
Report date
2020-05-27
Termination date
2021-11-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1270-2020