D-0549-2018 Class II Terminated
FDA drug recall D-0549-2018 was initiated by B. Braun Medical Inc on Feb 16, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jan 23, 2020). Affected quantity: 17,360 plastic irrigation containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 7, 2018
- Initiation Date
- Feb 16, 2018
- Termination Date
- Jan 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,360 plastic irrigation containers
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.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA
Code Information
Batch # J7N912, Exp 10/31/20
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0549-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026