0.9% Sodium Chloride Injection recall: Sterility Concern
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
Why was 0.9% Sodium Chloride Injection recalled?
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 5829936, Exp. MAR 31 2024
- Product
- 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
- Recalling firm
- ICU Medical Inc
- Quantity
- 137,120 bags
- Distribution
- Nationwide in the USA
- Recall date
- November 23, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)