Recall Z-0076-2019— Angiodynamics Inc. (Navilyst Medical Inc.)

Name: FDA recall Z-0076-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-24

Class II · Terminated

Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2018-07-24, terminated 2019-05-17. It names one FDA 510(k) clearance: K131694. Product: BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - 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: BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled.

Recalling firm: Angiodynamics Inc. (Navilyst Medical Inc.)
Classification: Class II
Status: Terminated
Initiated: 2018-07-24
Terminated: 2019-05-17
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K131694 — NMI PORT II CATHETERNavilyst Medical, Inc.·cleared 2013-08-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - 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 for recall

BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled

Data sourced from openFDA. This site is unofficial and independent of the FDA.