FDA Device recall Z-0504-2020
BIOFLO 8F SINGLE PLASTIC FILLED
- FDA Device
- Class II
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of BIOFLO 8F SINGLE PLASTIC FILLED by Angiodynamics Navilyst Medical, citing snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to conne….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0504-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-18 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | US |
Product
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Reason
Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
Identifiers
| code_info | 5478033, 5482424 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0504-2020%22
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