FDA Medical Device Recalls (openFDA)
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 blood specimen withdrawal.
- Recall number
- Z-0076-2019
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- 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.
- Status
- Terminated
- Initiated
- 2018-07-24
- Posted
- not on file
- Terminated
- 2019-05-17
- 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.
- Lot, serial or model codes
- Lot Number: 5363172
- 510(k) numbers
- ["K131694"]
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 3017892510
- Firm city
- Glens Falls
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28