FDA Device recall Z-0596-2019
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481 by Angiodynamics Navilyst Medical, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0596-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-16 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | FL |
Product
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
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.
Identifiers
| code_info | 5231609 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Angiodynamics Navilyst Medical
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FDA Device · Class II · 2021-04-28 · Angiodynamics Navilyst Medical - XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical - BIOFLO 8F SINGLE PLASTIC FILLED
FDA Device · Class II · 2019-11-27 · Angiodynamics Navilyst Medical
All Angiodynamics Navilyst Medical recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0596-2019%22
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