Recalls / Class II
Class IID-0883-2018
Product
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
- Affected lot / code info
- Lot #: 85-016-JT, Exp 01/01/2020
Why it was recalled
Lack of assurance of sterility: Bags have potential to leak.
Recalling firm
- Firm
- ICU Medical Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N FIELD DRIVE, N/A, LAKE FOREST, Illinois 60045
Distribution
- Quantity
- 525984 bags
- Distribution pattern
- Nationwide and Canada
Timeline
- Recall initiated
- 2018-05-31
- FDA classified
- 2018-06-20
- Posted by FDA
- 2018-06-27
- Terminated
- 2020-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0883-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.