Drug recall
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no…
FDA recall event 81477 · Class II · Angiodynamics Inc. (Navilyst Medical Inc.)
Key facts
| Event ID | 81477 |
|---|---|
| Recall numbers | Z-0595-2019, Z-0596-2019 |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Product type | Devices |
| Products | BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481, Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by…, Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by… |
| Initiation date | Oct 16, 2018 |
| Report date | Dec 19, 2018 |
| Termination date | Jun 26, 2020 |
| 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: