Recalls / Class II
Class IID-0216-2019
Product
0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
- Affected lot / code info
- Lots: a) 84-011-JT Exp. December 01, 2019 and 85-014-JT Exp. January 01, 2020; b) 84-015-JT Exp. December 01, 2019; c) 84-016-JT Exp. June 01, 2019; d) 84-005-JT Exp. December 01, 2019 and 84-014-JT Exp. December 01, 2019
Why it was recalled
Lack of Assurance of Sterility; bags have the potential to leak
Recalling firm
- Firm
- ICU Medical Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N FIELD DRIVE, LAKE FOREST, Illinois 60045
Distribution
- Quantity
- 2,580,448 bags
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2018-10-08
- FDA classified
- 2018-11-02
- Posted by FDA
- 2018-11-14
- Terminated
- 2021-03-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0216-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.