Drug recall
BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN…
FDA recall event 80913 · Class II · Angiodynamics Inc. (Navilyst Medical Inc.)
Key facts
| Event ID | 80913 |
|---|---|
| Recall numbers | Z-0076-2019 |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Product type | Devices |
| Products | BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F… |
| Initiation date | Jul 24, 2018 |
| Report date | Oct 17, 2018 |
| Termination date | May 17, 2019 |
| City | Glens Falls |
| State | NY |
| Country | United States |
| FEI number | 1317056 |
At a glance
- 1–9 Products in this recall
- None 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: