0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reported: November 23, 2022 Initiated: November 9, 2022 #D-0062-2023
Product Description
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason for Recall
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Details
- Recalling Firm
- ICU Medical Inc
- Units Affected
- 137,120 bags
- Distribution
- Nationwide in the USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37. Recalled by ICU Medical Inc. Units affected: 137,120 bags.
Why was this product recalled? ▼
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 23, 2022. Severity: Moderate. Recall number: D-0062-2023.
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