Dignity Dual Portdignity Dual Port
9.5F Plastic Dignity®dual CT Port W/Attachablect Port W/AT Chronoflex®polyurethane Catheter W/5F Micro-Stick® Introducer Setintroducer SET
2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
8recalls 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 | Medical Components 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, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-10-20 |
| Record revised | 2019-10-23 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5 |
| Distribution end date | 2019-09-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MICTI95002 | Withdrawn |
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 |
|---|---|
| K130923 | 2013-07-31 |
| K120281 | 2012-09-17 |
Recalls
6 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 |
|---|---|---|---|---|---|
| 2021-01-13 | Class II | Employee error | The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted | 96 pieces total (updated 3/11/2021 additional 72 pieces) | |
| 2017-11-22 | Class II | Mixed-up of materials/components | The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire. | 24 Eaches | 2018-07-11 |
| 2017-05-25 | Class II | Mixed-up of materials/components | The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip. | 65 units | 2018-09-04 |
| 2017-02-23 | Class II | Unknown/Undetermined by firm | The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit throug | 71 units | 2018-02-02 |
| 2015-01-28 | Class II | PMA | The dual port with catheters was not covered under FDA clearance. | 325 | 2017-01-06 |
| 2012-04-12 | Not classified | Employee error | 50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port. | 50 trays | 2013-07-18 |
| 2012-04-02 | Class II | Packaging process control | Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port. | 30 | 2013-05-20 |
| 2010-07-02 | Not classified | Employee error | Recalled product was packaged with the incorrect port and does not match the label. The kit is labeled as a 6.6F “Dignity” Low Profile CT Port. The kit contains a 6.6F “Pro-Fuse” Low Profile CT Port. | 47 units | 2010-10-13 |
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.