0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 6
Summary
The FDA issued a Class II for 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU by ICU Medical Inc. Reason: Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility..
Details
Source
Drug Recall
External ID
D-0062-2023
Action Date
2022-11-23
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot: 5829936, Exp. MAR 31 2024
Quantity Affected: 137,120 bags
Reason for Recall
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-09
Company
Lake Forest, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 23 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
ICU Medical Inc has 95 FDA actions in our database, including 85 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ICU Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ICU Medical Inc have FDA actions?
ICU Medical Inc has 95 FDA actions in our database, including 85 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0062-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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