FDA Recall D-1270-2020
ICU Medical Inc · Lake Forest, IL
Class I — life-threatening Terminated 551 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1270-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide within the United States
- Recall initiated
- 2020-05-08
- Classified by FDA Center
- 2020-05-19
- FDA published
- 2020-05-27
- Terminated
- 2021-11-10
- Recalling firm
- ICU Medical Inc
- Firm location
- Lake Forest, IL