BioFlo
BioFlo Titanium Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Polyurethane Catheter with ENDEXO Technology
2manufacturers in China registered for this device type
14catalogue numbers in this listing
3510(k) clearances naming this product code
31recalls on this code
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
Record
| Listed by | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | LJT |
| Device type | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5965 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K153228 |
| Record published | 2024-09-20 |
| Record revised | 2026-07-03 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 63 cm; catheter gauge 6 to 8 Fr; outer diameter 2.1 to 2.6 mm; lumen/inner diameter 1.3 to 1.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H965440210 | Length 63 cm | In distribution |
| H965440270 | Length 63 cm | In distribution |
| H965440140 | Lumen/Inner Diameter 1.6 mm | In distribution |
| H965440170 | Catheter Gauge 8 Fr | In distribution |
| H965440110 | Lumen/Inner Diameter 1.3 mm | In distribution |
| H965440220 | Length 63 cm | In distribution |
| H965440120 | Outer Diameter 2.1 mm | In distribution |
| H965440230 | Lumen/Inner Diameter 1.3 mm | In distribution |
| H965440280 | Outer Diameter 2.6 mm | In distribution |
| H965440200 | Outer Diameter 2.1 mm | In distribution |
| H965440250 | Lumen/Inner Diameter 1.6 mm | In distribution |
| H965440130 | Length 63 cm | In distribution |
| H965440150 | Catheter Gauge 6 Fr | In distribution |
| H965440190 | Catheter Gauge 6 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dignity® | Medical Components Inc | 168 |
| Deltec | ICU Medical, Inc | 130 |
| NorPort Vascular Access Port | Norfolk Medical | 106 |
| BioFlo Vortex | AngioDynamics, Inc. | 60 |
| BioFlo Vortex | Navilyst Medical, Inc. | 59 |
| Dignity® MID-Sized CT Port | Medical Components Inc | 55 |
| TidalPort Vascular Access Port | Norfolk Medical | 52 |
| Pro-Fuse® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Mini CT Port | Medical Components Inc | 44 |
| Medcomp GEN III Power Injectable Portmedcomp GEN III Power Injectable Port | Medical Components Inc | 29 |
| PRO-Fuse® | Medical Components Inc | 28 |
Showing 12 of 96. All products under Port & Catheter, Implanted, Subcutaneous, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190559 | 2020-05-22 |
| K101017 | 2010-06-17 |
| K081472 | 2008-09-23 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-09-20 | Class II | Under Investigation by firm | Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, fa | 11 units | |
| 2021-02-22 | Class II | Under Investigation by firm | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified be | 267 kits | 2022-07-19 |
| 2019-09-18 | Class II | Under Investigation by firm | 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 implan | 582 | 2020-09-24 |
| 2019-09-18 | Class II | Under Investigation by firm | 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 implan | 582 | 2020-09-24 |
| 2019-09-18 | Class II | Under Investigation by firm | 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 implan | 582 | 2020-09-24 |
| 2019-09-18 | Class II | Under Investigation by firm | 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 implan | 582 | 2020-09-24 |
| 2019-09-18 | Class II | Under Investigation by firm | 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 implan | 582 | 2020-09-24 |
| 2018-07-24 | Class II | Unknown/Undetermined by firm | 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 | 1 box | 2019-05-17 |
| 2010-08-30 | Not classified | Labeling False and Misleading | The labeling contains errors which result in the products being misbranded | 41 units | 2012-03-12 |
| 2010-08-30 | Not classified | Labeling False and Misleading | The labeling contains errors which result in the products being misbranded | 69 units | 2012-03-12 |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2010-05-13 | Not classified | Nonconforming Material/Component | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | 2012-08-03 | |
| 2009-07-16 | Not classified | Packaging process control | The product may contain an incorrect size catheter and introducer. | 150 kits | 2010-10-27 |
| 2007-10-03 | Not classified | Employee error | Incorrect Size Catheter: The product may contain an incorrect size catheter. | 150 kits | 2008-07-14 |
| 2006-09-27 | Not classified | Other | Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised. | Domestic – 42 | 2007-11-26 |
| 2006-09-27 | Not classified | Other | Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised. | Domestic – 194 | 2007-11-26 |
| 2006-06-13 | Not classified | Other | Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath–(Recalling Firm was notified by supplier B. Braun Medical of the error) | 22 | 2007-04-23 |
| 2006-06-13 | Not classified | Other | Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath–(Recalling Firm was notified by their supplier B. Braun Medical of the error) | 5 | 2007-04-23 |
| 2004-09-20 | Not classified | Other | The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer. | 44 kits | 2005-03-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.