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
Reported: November 14, 2018 Initiated: October 8, 2018 #D-0216-2019
Product Description
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
Reason for Recall
Lack of Assurance of Sterility; bags have the potential to leak
Details
- Recalling Firm
- ICU Medical Inc
- Units Affected
- 2,580,448 bags
- Distribution
- Nationwide.
- Location
- LAKE FOREST, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by ICU Medical Inc. Units affected: 2,580,448 bags.
Why was this product recalled? ▼
Lack of Assurance of Sterility; bags have the potential to leak
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 14, 2018. Severity: Moderate. Recall number: D-0216-2019.
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