Drug recall
0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical…
FDA recall event 79348 · Class II · B. Braun Medical Inc
Key facts
| Event ID | 79348 |
|---|---|
| Recall numbers | D-0549-2018 |
| Recalling firm | B. Braun Medical Inc |
| Product type | Drugs |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Feb 16, 2018 |
| Report date | Mar 7, 2018 |
| Termination date | Jan 23, 2020 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 2021236 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: