Drug recall
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA…
FDA recall event 78767 · Class II · B. Braun Medical Inc
Key facts
| Event ID | 78767 |
|---|---|
| Recall numbers | D-0112-2018 |
| Recalling firm | B. Braun Medical Inc |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap |
| Initiation date | Dec 15, 2017 |
| Report date | Dec 27, 2017 |
| Termination date | Oct 18, 2018 |
| 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: