Recalls / Class II
Class IID-0509-2019
Product
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
- Affected lot / code info
- Lot #: 91-016-JT, Exp. July 01, 2020
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- ICU Medical Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N FIELD DRIVE, LAKE FOREST, Illinois 60045
Distribution
- Quantity
- 475320 bags
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-02-04
- FDA classified
- 2019-02-19
- Posted by FDA
- 2019-02-27
- Terminated
- 2020-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0509-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.