Drug recall
Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
FDA recall event 84365 · Class II · B. Braun Medical, Inc.
Key facts
| Event ID | 84365 |
|---|---|
| Recall numbers | Z-0935-2020, Z-0936-2020, Z-0937-2020, Z-0938-2020, Z-0939-2020, Z-0940-2020, Z-0941-2020 |
| Recalling firm | B. Braun Medical, Inc. |
| Product type | Devices |
| Products | Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005, Safeline Y-Type Blood Set, Catalog Number NF5140, Safeline Y-Type Blood Set, Catalog Number V2500, Y-Type Blood Set, Catalog Number 490293, Y-Type Blood Set, Catalog Number 490314 and 2 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for leakage at the joint between the blood filters and tubing |
| Initiation date | Nov 20, 2019 |
| Report date | Feb 12, 2020 |
| Termination date | Oct 16, 2020 |
| City | Allentown |
| State | PA |
| Country | United States |
| FEI number | 2523676 |
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: