Class II — Angiodynamics Inc. (Navilyst Medical Inc.)
| Recalling firm | ANGIODYNAMICS, INC |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date. |
| Product | Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711 |
| Quantity | Box of 1 Units |
| Distribution | Distributed to accounts in Florida. Foreign distribution to Great Britain. |
| Initiated | 2018-10-16 |
| Classified | 2018-12-11 |
| Terminated | 2020-06-26 |
| Recall number | Z-0595-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Angiodynamics Inc. (Navilyst Medical Inc.) (Z-0595-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81477/
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