Sodium Chloride Irrigant
FDA Recall NDC 0264-2201
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Sodium Chloride (NDC 0264-2201). A significant event, classified as Class II, was initiated on Mar 31, 2025 by B. Braun Medical Inc.. The reported reason for this action was: "Presence of Particulate Matter"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Particulate Matter
Mar 31, 2025
Apr 16, 2025
32,256 Bottles
Recall Profile & Regulatory Data
Event ID
96605
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 12 distributors who may have further distributed the product nationwide.
Product Description
0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10
Batch or Lot Expiration Information
Lot# J4K936, Exp 7/31/2027
Affected Packages Involved in this Recall
0264-2201-00Product
0264-2201-10Product
0264-2201-50Product
0264-2201-70Product
Class II Terminated
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
Feb 16, 2018
Mar 07, 2018
17,360 plastic irrigation containers
Recall Profile & Regulatory Data
Event ID
79348
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jan 23, 2020
Product Description
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.
Batch or Lot Expiration Information
Batch# J7N912, Exp 10/31/20
Affected Packages Involved in this Recall
0264-2201-00Product
0264-2201-10Product
0264-2201-50Product
0264-2201-70Product
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.
