FDA Recall D-0805-2021
ICU Medical Inc · Lake Forest, IL
Class I — life-threatening Terminated 677 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17
Reason for recall
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Recall record
- Recall number
D-0805-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2021-09-03
- Classified by FDA Center
- 2021-09-17
- FDA published
- 2021-09-22
- Terminated
- 2023-07-12
- Recalling firm
- ICU Medical Inc
- Firm location
- Lake Forest, IL