FDA Recall D-0350-2020
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
0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
Reason for recall
Presence of Particulate Matter.
Recall record
- Recall number
D-0350-2020- 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