Statlock IV
StatLock IV Select Luer retainer, Select pads, macro bore 6in Luer lock extension set for low pressure power injectors with MicroCLAVE valve 25 box
49manufacturers in China registered for this device type
50catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wenzhou K.L.F. Medical Plastics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular
Record
| Listed by | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-14 |
| Record revised | 2024-09-26 (version 3) |
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, manufacturing date |
| Packaging | Box of 10, case of 25 |
| Sizes | Length 4 to 12 in |
| Distribution end date | 2023-05-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IV0503 | Length 6 in | In distribution |
| IV0583 | Length 6 in | In distribution |
| IV0225 | Length 6 in | In distribution |
| IV0540 | Length 6 in | In distribution |
| VITML6 | Length 6 in | In distribution |
| IV0221 | Length 6 in | In distribution |
| IV0551 | Length 6 in | In distribution |
| IV0261 | Length 6 in | In distribution |
| IV0565 | Length 6 in | In distribution |
| IV0563CE | Length 6 in | In distribution |
| IV0541 | Length 6 in | In distribution |
| IV0563 | Length 6 in | In distribution |
| IV0521 | Length 6 in | In distribution |
| IV0529 | Length 9 in | In distribution |
| IV0644P | Length 6 in | In distribution |
| IV0521CE | Length 6 in | In distribution |
| IV0584 | Length 9 in | In distribution |
| IV0260 | Length 6 in | In distribution |
| IV0525 | Length 6 in | In distribution |
| IV0525CE | Length 6 in | In distribution |
| IV0502 | Length 4 in | In distribution |
| IV0553 | Length 6 in | In distribution |
| IV0532 | Length 7 in | In distribution |
| IV0502CE | Length 4 in | In distribution |
| IV0572P | Length 6 in | In distribution |
| IV0558 | Length 4 in | In distribution |
| IV0572 | Length 6 in | In distribution |
| IV0525P | Length 6 in | In distribution |
| IV0566 | Length 9 in | In distribution |
| VIDTML4 | Length 4 in | In distribution |
| IV0564 | Length 6 in | In distribution |
| IV0597 | Length 6 in | In distribution |
| IV0506 | Length 4 in | In distribution |
| IV0640 | Length 6 in | In distribution |
| VIDML6 | Length 6 in | In distribution |
| IV0263 | Length 6 in | In distribution |
| IV0563P | Length 6 in | In distribution |
| IV0639 | Length 6 in | In distribution |
| IV0527 | Length 12 in | In distribution |
| IV0550 | Length 6 in | In distribution |
| IV0221CE | Length 6 in | In distribution |
| IV0555 | Length 7 in | In distribution |
| VIDML12 | Length 12 in | In distribution |
| IV0571 | Length 6 in | In distribution |
| VITML6AV | Length 6 in | In distribution |
| IV0591 | Length 7 in | In distribution |
| IV0548 | Length 4 in | In distribution |
| IV0653P | Length 6 in | In distribution |
| IV0651P | Length 6 in | Withdrawn |
| IV0531 | Length 7 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 529 |
| Codan | Codan US Corp. | 510 |
| Vygon | Vygon Corp. | 355 |
| Port Access Needle | Bard Access Systems, Inc. | 341 |
| Set, Administration, Intravascular | Mps Medical, Inc. | 291 |
| Alaris, SmartSite | BD Switzerland Sàrl | 266 |
| IV Administration Set | B. Braun Medical Inc. | 242 |
| Medex | ICU Medical, Inc | 237 |
| Extension Set | B. Braun Medical Inc. | 171 |
| MaxGuard | BD Switzerland Sàrl | 150 |
| Medline | Medline Industries, Inc. | 148 |
| Centurion | Centurion Medical Products Corporation | 145 |
Showing 12 of 768. All products under Set, Administration, Intravascular
Recalls
4 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 |
|---|---|---|---|---|---|
| 2016-12-19 | Class II | Mixed-up of materials/components | Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the need | 8000 units | 2017-04-17 |
| 2016-12-19 | Class II | Mixed-up of materials/components | Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the need | 7,200 units | 2017-04-17 |
| 2015-03-13 | Class II | Labeling False and Misleading | Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit po | 700 units | 2015-06-24 |
| 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 | 135,284 units | 2015-08-05 |
| 2010-01-14 | Not classified | Component change control | After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury. | 775 units | 2010-05-14 |
| 2010-01-14 | Not classified | Component change control | After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury. | 4,975 units | 2010-05-14 |
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.