0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corpora
Summary
The FDA issued a Class I for 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 u by Baxter Healthcare Corporation. Reason: Presence of particulate matter: Particulates identified as fiberglass.
Details
Source
Drug Recall
External ID
D-0849-2026
Action Date
2026-09-09
Status
Ongoing
Category
drug
Product Description
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03
Lot/Code Info: Lot: Y495523, Y495523A, Exp 31-Oct-2027
Quantity Affected: 145,464 500mL bags
Reason for Recall
Presence of particulate matter: Particulates identified as fiberglass
Distribution
Natonwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-17
Company
Deerfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 53 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Baxter Healthcare Corporation has 335 FDA actions in our database, including 311 recalls and 24 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 335 FDA actions in our database, including 311 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0849-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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