FDA Recall D-0349-2020
ICU Medical Inc · Lake Forest, IL
Class I — life-threatening Terminated 818 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, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
Reason for recall
Presence of Particulate Matter.
Recall record
- Recall number
D-0349-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA.
- Recall initiated
- 2019-10-25
- Classified by FDA Center
- 2019-11-15
- FDA published
- 2019-11-13
- Terminated
- 2022-01-20
- Recalling firm
- ICU Medical Inc
- Firm location
- Lake Forest, IL