Recall Z-0076-2019 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Angiodynamics Inc. (Navilyst Medical Inc.)
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 bl
| Date | Jul 24, 2018 |
| Status | Terminated |
| 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 |
| Root cause | Unknown/Undetermined by firm |
| Action | On July 24, 2018 AngioDynamics initiated this recall action by notifying the affected consignee via telephone call.Per the telephone conversation, the consignee was instructed to segregate the affected device and quarantine the product until further direction from AngioDynamics. A follow-up letter issued dated 7/24/18 email response form to be completed and returned. |
| Quantity | 1 box |
| Distribution | US Nationwide in the state of IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131694 | NMI PORT II CATHETER Navilyst Medical, Inc., Aug 8, 2013 |