Sodium Chloride Irrigant
FDA Recall NDC 0338-0047
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sodium Chloride (NDC 0338-0047). A significant event, classified as Class II, was initiated on Nov 19, 2019 by Baxter Healthcare Company. The reported reason for this action was: "Lack of Assurance of Sterility: Product has the potential to leak."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: Product has the potential to leak.
Nov 19, 2019
Nov 27, 2019
22336 bags
Recall Profile & Regulatory Data
Event ID
84288
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Feb 04, 2021
Product Description
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Batch or Lot Expiration Information
Lot# : Y309971, Y309971A, Exp. date 6/30/2021
Affected Packages Involved in this Recall
0338-0047-24Product
0338-0047-27Product
0338-0047-29Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
