Acetic Acid Irrigant
FDA Recall NDC 0264-2304
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 Acetic Acid (NDC 0264-2304). A significant event, classified as Class II, was initiated on Dec 15, 2017 by B. Braun Medical Inc.. The reported reason for this action was: "Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap"
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
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Dec 15, 2017
Dec 27, 2017
2,576 containers
Recall Profile & Regulatory Data
Event ID
78767
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide.
Termination Date
Oct 18, 2018
Product Description
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
Batch or Lot Expiration Information
Lot# : J7N965, Exp. 10/31/2020
Affected Packages Involved in this Recall
0264-2304-00Product
0264-2304-10Product
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.
