FDA Device recall Z-0503-2020
BIOFLO 8F SINGLE PLASTIC NON-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 NON-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-0503-2020 |
| 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 NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
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 | 5478023 |
|---|
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-0503-2020%22
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