FDA Medical Device Recalls (openFDA)
Angiodynamics Inc. (Navilyst Medical Inc.): BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - 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-0501-2020
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Product
- BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - 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
- 2019-09-18
- Posted
- not on file
- Terminated
- 2020-09-24
- 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.
- Root cause
- Under Investigation by firm
- Action
- On September 18, 2019, AngioDynamics sent Urgent Voluntary Medical Device Letters to impacted consignees. Customers were asked to do the following: IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to AngioDynamics, Inc. o Forward a copy of this recall notification to all sites to which you have distributed affected product. IN THE EVENT THAT THE PORT PRODUCT UNDER RECALL HAS BEEN UTILIZED (IMPLANTED) o The occurrence rate of an out of specification snap lock connector is less than 100%. o A port kit containing a properly sized snap lock connector allows the catheter to be securely attached to the port. o There are no actions required for an implanted port with a properly attached catheter. Customers were asked to complete and return the Reply Verification Form, and to package and return the recalled product.
- Quantity
- 582
- Distribution
- Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.
- Lot, serial or model codes
- 5487932, 5487933, 5488008
- 510(k) numbers
- ["K122767"]
- 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