Xcela Power Injectable PICC with PASV — Class II medical device recall Z-0595-2019
Terminated recall by Angiodynamics Inc. (Navilyst Medical Inc.), reported 2018-12-19, distributed in FL. Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The lab
| Recall number | Z-0595-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY, United States |
| Recall initiated | 2018-10-16 |
| Classified | 2018-12-11 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2020-06-26 |
| Distributed | FL |
| Countries outside the US | GB |
| Quantity | 1 units |
| Reason classes | labeling |
| Lot numbers | 5096448 |
| Model numbers | 55-711 |
Product
Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0595-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.