PowerLine
PowerLine Central Venous Catheter. 6F Triple-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff. Microintroducer Kit
5manufacturers in China registered for this device type
6catalogue numbers in this listing
6510(k) clearances naming this product code
39recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2024-08-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 | Case of 5 |
| Sizes | Length 50 cm; catheter gauge 5 to 6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0730610 | Length 50 cm | In distribution |
| 0720515 | Length 50 cm | In distribution |
| 0730615 | Length 50 cm | In distribution |
| 0700610 | Length 50 cm | In distribution |
| 0700515 | Catheter Gauge 5 Fr | In distribution |
| 0700615 | Length 50 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Cook Spectrum Turbo-Ject | Cook Incorporated | 73 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Synergy | Health Line International Corporation | 53 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222232 | 2022-08-24 |
| K210264 | 2021-07-30 |
| K053501 | 2006-01-13 |
| K051672 | 2005-11-23 |
| K935380 | 1995-02-17 |
| K926331 | 1994-03-07 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-05-21 | Class II | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | 120 | |
| 2026-05-21 | Class II | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | 39,245 | |
| 2026-05-21 | Class II | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | 66 | |
| 2026-05-21 | Class II | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | 29,490 | |
| 2026-05-21 | Class II | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. | 624 | |
| 2025-03-11 | Class I | Process control | Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extrava | 718,461 | |
| 2021-05-19 | Class II | Process control | Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire. | 30 kits | 2023-03-31 |
| 2021-05-19 | Class II | Process control | Catheter kits contained the incorrect micro-introducers. | 180 units | 2023-01-24 |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2021-04-07 | Class II | Process control | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the ina | 2023-06-01 | |
| 2017-12-28 | Class II | Labeling design | Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction. | 53,699 units total | 2021-06-14 |
| 2015-07-20 | Class II | Labeling False and Misleading | Bard Access Systems is recalling marketing brochures for the PowerPICC and PowerPICC SOLO catheters due to incorrect indication for use contained in the brochure. | 1811 | 2017-02-10 |
| 2015-05-27 | Class III | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. | 2016-02-10 | |
| 2015-05-27 | Class III | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. | 2016-02-10 | |
| 2015-05-27 | Class III | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. | 2016-02-10 | |
| 2015-05-27 | Class III | Labeling Change Control | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. | 2016-02-10 | |
| 2014-08-08 | Class II | Nonconforming Material/Component | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), Power | 134,554 units | 2015-08-05 |
| 2011-06-20 | Not classified | Labeling design | Kit label indicates the wrong dimension for an enclosed introducer. | 6,485 units | 2012-03-01 |
| 2010-12-10 | Not classified | Employee error | Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits. | 195 units | 2011-05-04 |
| 2005-12-20 | Not classified | Other | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warning | 743 units | 2009-08-11 |
| 2005-12-20 | Not classified | Other | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnin | 88 units | 2009-08-11 |
| 2005-12-20 | Not classified | Other | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnin | 567 units | 2009-08-11 |
| 2005-12-20 | Not classified | Other | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnin | 450 | 2009-08-11 |
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.