0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-352
Summary
The FDA issued a Class II for 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Br by B. Braun Medical Inc.. Reason: Lack of assurance of sterility: bags have the potential to leak..
Details
Source
Drug Recall
External ID
D-0916-2023
Action Date
2023-07-19
Status
Terminated
Category
drug
Product Description
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
Lot/Code Info: Lot#: 0061858305, 0061858306 Exp 3/31/2025
Quantity Affected: 79,880 bags
Reason for Recall
Lack of assurance of sterility: bags have the potential to leak.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-05
Company
Daytona Beach, FL
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 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
B. Braun Medical Inc. has 282 FDA actions in our database, including 269 recalls and 13 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 (B. Braun 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 B. Braun Medical Inc. have FDA actions?
B. Braun Medical Inc. has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0916-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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