FDAFDA · Food and drugs·Recall number D-0216-2019
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
Published November 14, 2018 · Recall initiated: October 8, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; bags have the potential to leak
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical Inc
- Distributor
- Nationwide.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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