Port Access Needle
HuberPlus 19G x 1.25" with Y-Site and Needless Injection Site
49manufacturers in China registered for this device type
341catalogue 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 | 2016-08-09 |
| Record revised | 2024-09-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 25, box of 8, case of 20, box of 4, case of 8, box of 24 |
| Sizes | Needle gauge 19 to 22 G; length 0.5 to 1.5 in; length 13 to 15 mm; total volume 0.25 to 0.35 ml |
| Distribution end date | 2024-01-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SHG622-75YS | Needle Gauge 22 G | In distribution |
| SHG620-50YS | Needle Gauge 20 G | In distribution |
| SHW20-75 | Needle Gauge 20 G | In distribution |
| SH20-100 | Needle Gauge 20 G | In distribution |
| SHW19-75Y | Needle Gauge 19 G | In distribution |
| SH22-100Y | Needle Gauge 22 G | In distribution |
| SHW22-75Y | Needle Gauge 22 G | In distribution |
| SHG22-100 | Needle Gauge 22 G | In distribution |
| SHG22-100Y | Length 1 in | In distribution |
| SH22-100YS | Length 1 in | In distribution |
| SHW22-75YS | Needle Gauge 22 G | In distribution |
| SH22-150Y | Length 1.5 in | In distribution |
| 012201 | Needle Gauge 22 G | In distribution |
| S02320-10 | Length 1 in | In distribution |
| 0671934 | Length 0.75 in | In distribution |
| SHW22-50YS | Needle Gauge 22 G | In distribution |
| SHG620-75Y | Needle Gauge 20 G | In distribution |
| SHG19-150 | Needle Gauge 19 G | In distribution |
| LH-0038 | Needle Gauge 20 G | In distribution |
| LH-0032YN | Needle Gauge 20 G | In distribution |
| SHG19-150Y | Needle Gauge 19 G | In distribution |
| SHW19-150YS | Needle Gauge 19 G | In distribution |
| SHG619-100YS | Needle Gauge 19 G | In distribution |
| 0652015 | Needle Gauge 20 G | In distribution |
| 0662234 | Needle Gauge 22 G | In distribution |
| 0141910 | Needle Gauge 19 G | In distribution |
| S01022-75 | Needle Gauge 22 G | In distribution |
| SH22-150 | Length 1.5 in | In distribution |
| 011912NY | Length 1.25 in | In distribution |
| 0651915 | Needle Gauge 19 G | In distribution |
| LH-0034YN | Size = Priming Volume = 0.7 millilitre (mL) | In distribution |
| S01020-15 | Needle Gauge 20 G | In distribution |
| LH-0037 | Needle Gauge 20 G | In distribution |
| 0661910 | Needle Gauge 19 G | In distribution |
| SHG22-50YS | Length 0.5 in | In distribution |
| SH19-75 | Needle Gauge 19 G | In distribution |
| 0652034 | Length 0.75 in | In distribution |
| SH19-100 | Needle Gauge 19 G | In distribution |
| 0671910 | Needle Gauge 19 G | In distribution |
| S02020-50FK | Needle Gauge 20 G | In distribution |
| 011912 | Length 1.25 in | In distribution |
| 0141975 | Needle Gauge 19 G | In distribution |
| LH-0029 | Needle Gauge 22 G | In distribution |
| S02022-10FK | Length 1 in | In distribution |
| LH-0031YN | Length 0.75 in | In distribution |
| 0131915 | Needle Gauge 19 G | In distribution |
| SHG620-100 | Needle Gauge 20 G | In distribution |
| SHG620-150Y | Length 1.5 in | In distribution |
| 0652234 | Needle Gauge 22 G | In distribution |
| SHG20-75YS | Needle Gauge 20 G | In distribution |
| 0642234 | Needle Gauge 22 G | In distribution |
| S02019-75FK | Needle Gauge 19 G | In distribution |
| 0672034 | Needle Gauge 20 G | In distribution |
| SH20-75YS | Needle Gauge 20 G | In distribution |
| SHG620-75 | Needle Gauge 20 G | In distribution |
| 0681934 | Length 0.75 in | In distribution |
| 0682210 | Needle Gauge 22 G | In distribution |
| 0662015 | Length 1.5 in | In distribution |
| S02020-10FK | Needle Gauge 20 G | In distribution |
| SH20-75Y | Length 0.75 in | In distribution |
| 0632010 | Needle Gauge 20 G | In distribution |
| 0682015 | Needle Gauge 20 G | In distribution |
| SH20-100YS | Length 1 in | In distribution |
| 0642215 | Needle Gauge 22 G | In distribution |
| S02019-10FK | Needle Gauge 19 G | In distribution |
| 0682234 | Needle Gauge 22 G | In distribution |
| LH-0030YN | Length 1 in | In distribution |
| SHG619-150 | Needle Gauge 19 G | In distribution |
| LH-0029YN | Length 0.75 in | In distribution |
| S02022-75FK | Length 0.75 in | In distribution |
| 011901NY | Length 1 in | In distribution |
| LH-0039YN | Needle Gauge 19 G | In distribution |
| SHG22-75Y | Length 0.75 in | In distribution |
| SH19-75YS | Length 0.75 in | In distribution |
| 0132075 | Length 0.75 in | In distribution |
| LH-0031 | Needle Gauge 20 G | In distribution |
| SHG620-150YS | Length 1.5 in | In distribution |
| SH19-100YS | Length 1 in | In distribution |
| SHW22-100 | Length 1 in | In distribution |
| LH-0035 | Size = Priming Volume = 0.3 millilitre (mL) | In distribution |
| S02320-75 | Needle Gauge 20 G | In distribution |
| S01019-75 | Length 0.75 in | In distribution |
| 0132015 | Length 1.5 in | In distribution |
| 0651934 | Needle Gauge 19 G | In distribution |
| SHG22-150Y | Needle Gauge 22 G | In distribution |
| SHG20-100YS | Needle Gauge 20 G | In distribution |
| LH-0032 | Length 1 in | In distribution |
| SHW20-50YS | Length 0.5 in | In distribution |
| 0672010 | Length 1 in | In distribution |
| 0662215 | Length 1.5 in | In distribution |
| 0132215 | Needle Gauge 22 G | In distribution |
| S02322-10 | Length 1 in | In distribution |
| 0671915 | Needle Gauge 19 G | In distribution |
| 579116 | Length 1.5 in | In distribution |
| SH19-150Y | Needle Gauge 19 G | In distribution |
| SHG22-100YS | Length 1 in | In distribution |
| SHG619-150YS | Length 1.5 in | In distribution |
| SHG619-150Y | Needle Gauge 19 G | In distribution |
| SH22-75 | Needle Gauge 22 G | In distribution |
| SHG20-75 | Needle Gauge 20 G | In distribution |
| 012215NY | Length 1.5 in | In distribution |
| SHG20-50YS | Length 0.5 in | In distribution |
| SHN20-50 | Needle Gauge 20 G | In distribution |
| SHN19-60 | Needle Gauge 19 G | In distribution |
| 0642034 | Needle Gauge 20 G | In distribution |
| SHN20-60 | Needle Gauge 20 G | In distribution |
| SH22-75Y | Length 0.75 in | In distribution |
| LH-0038YN | Needle Gauge 20 G | In distribution |
| SHG22-75 | Needle Gauge 22 G | In distribution |
| SHW19-75YS | Needle Gauge 19 G | In distribution |
| SHG22-150YS | Needle Gauge 22 G | In distribution |
| 011934NY | Length 0.75 in | In distribution |
| 0672210 | Length 1 in | In distribution |
| 0142010 | Length 1 in | In distribution |
| SH20-150YS | Length 1.5 in | In distribution |
| SHW22-150YS | Length 1.5 in | In distribution |
| SHG19-150YS | Needle Gauge 19 G | In distribution |
| SHG19-100YS | Needle Gauge 19 G | In distribution |
| SH20-100Y | Needle Gauge 20 G | In distribution |
| SHN22-60 | Needle Gauge 22 G | In distribution |
| 0662010 | Length 1 in | In distribution |
| SHG19-100Y | Length 1 in | In distribution |
| SHG19-75YS | Needle Gauge 19 G | In distribution |
| 577114 | Needle Gauge 22 G | In distribution |
| SHG22-150 | Needle Gauge 22 G | In distribution |
| 0652215 | Length 1.5 in | In distribution |
| SHG20-150 | Needle Gauge 20 G | In distribution |
| SHG622-50YS | Needle Gauge 22 G | In distribution |
| 012215 | Length 1.5 in | In distribution |
| SHW20-100Y | Needle Gauge 20 G | In distribution |
| 581112 | Needle Gauge 19 G | In distribution |
| SH22-50YS | Needle Gauge 22 G | In distribution |
| 0661934 | Needle Gauge 19 G | In distribution |
| SHW20-100YS | Needle Gauge 20 G | In distribution |
| 012005 | Needle Gauge 20 G | In distribution |
| 8672034 | Length 0.75 in | In distribution |
| 0132210 | Needle Gauge 22 G | In distribution |
| 012015NY | Needle Gauge 20 G | In distribution |
| 012012NY | Length 1.25 in | In distribution |
| 0142215 | Needle Gauge 22 G | In distribution |
| 0652010 | Needle Gauge 20 G | In distribution |
| 012001NY | Length 1 in | In distribution |
| 012234 | Needle Gauge 22 G | In distribution |
| 0662034 | Length 0.75 in | In distribution |
| 011934 | Length 0.75 in | In distribution |
| SHN22-50 | Length 13 mm | In distribution |
| SHW20-75YS | Needle Gauge 20 G | In distribution |
| SHG19-100 | Needle Gauge 19 G | In distribution |
| SHW19-100Y | Length 1 in | In distribution |
| 0131975 | Needle Gauge 19 G | In distribution |
| SH22-150YS | Length 1.5 in | In distribution |
| SHG622-150YS | Length 1.5 in | In distribution |
| SHW20-150Y | Needle Gauge 20 G | In distribution |
| SH22-75YS | Needle Gauge 22 G | In distribution |
| SHW22-150Y | Length 1.5 in | In distribution |
| SH19-150 | Needle Gauge 19 G | In distribution |
| SHW22-150 | Needle Gauge 22 G | In distribution |
| LH-0033 | Needle Gauge 19 G | In distribution |
| 581114 | Needle Gauge 19 G | In distribution |
| LH-0040YN | Needle Gauge 19 G | In distribution |
| S02019-50FK | Needle Gauge 19 G | In distribution |
| SHG620-150 | Needle Gauge 20 G | In distribution |
| 0682215 | Length 1.5 in | In distribution |
| SHG622-100Y | Needle Gauge 22 G | In distribution |
| 011901 | Needle Gauge 19 G | In distribution |
| 0632050 | Needle Gauge 20 G | In distribution |
| 0632210 | Needle Gauge 22 G | In distribution |
| 0641910 | Needle Gauge 19 G | In distribution |
| LH-0040 | Needle Gauge 19 G | In distribution |
| 0631950 | Needle Gauge 19 G | In distribution |
| SHG619-75 | Needle Gauge 19 G | In distribution |
| SH20-150 | Length 1.5 in | In distribution |
| SHW19-150 | Needle Gauge 19 G | In distribution |
| S02322-75 | Length 0.75 in | In distribution |
| 0142275 | Needle Gauge 22 G | In distribution |
| 012212NY | Needle Gauge 22 G | In distribution |
| 587116 | Length 1.5 in | In distribution |
| SHW22-100YS | Needle Gauge 22 G | In distribution |
| S01022-15 | Needle Gauge 22 G | In distribution |
| 0632215 | Length 1.5 in | In distribution |
| 0651910 | Length 1 in | In distribution |
| 585110 | Needle Gauge 20 G | In distribution |
| S02319-75 | Needle Gauge 19 G | In distribution |
| 011915 | Needle Gauge 19 G | In distribution |
| 583116 | Needle Gauge 22 G | In distribution |
| LH-0037YN | Needle Gauge 20 G | In distribution |
| 012001 | Needle Gauge 20 G | In distribution |
| SHG622-100 | Length 1 in | In distribution |
| SH19-150YS | Needle Gauge 19 G | In distribution |
| 0672015 | Needle Gauge 20 G | In distribution |
| 0681915 | Needle Gauge 19 G | In distribution |
| 8652034 | Needle Gauge 20 G | In distribution |
| SHG619-75Y | Length 0.75 in | In distribution |
| SHG619-100 | Length 1 in | In distribution |
| SHG622-100YS | Needle Gauge 22 G | In distribution |
| LH-0030 | Length 1 in | In distribution |
| 0681910 | Length 1 in | In distribution |
| SHW20-150 | Length 1.5 in | In distribution |
| 012234NY | Length 0.75 in | In distribution |
| 0641915 | Needle Gauge 19 G | In distribution |
| S01022-10 | Needle Gauge 22 G | In distribution |
| 0631934 | Length 0.75 in | In distribution |
| SHG622-150Y | Needle Gauge 22 G | In distribution |
| S02020-75FK | Length 0.75 in | In distribution |
| 0632015 | Length 1.5 in | In distribution |
| SHG20-100 | Needle Gauge 20 G | In distribution |
| 011915NY | Length 1.5 in | In distribution |
| 0642010 | Length 1 in | In distribution |
| SHG620-100Y | Needle Gauge 20 G | In distribution |
| 0662210 | Needle Gauge 22 G | In distribution |
| S02020-15FK | Needle Gauge 20 G | In distribution |
| LH-0035YN | Size = Priming Volume = 0.7 millilitre (mL) | In distribution |
| SHG622-75Y | Length 0.75 in | In distribution |
| SHG620-100YS | Length 1 in | In distribution |
| S02019-15FK | Length 1.5 in | In distribution |
| SH19-100Y | Needle Gauge 19 G | In distribution |
| S02022-15FK | Needle Gauge 22 G | In distribution |
| 0141915 | Length 1.5 in | In distribution |
| LH-0036 | Length 1.5 in | In distribution |
| 0682010 | Length 1 in | In distribution |
| SHW20-100 | Length 1 in | In distribution |
| 0132010 | Needle Gauge 20 G | In distribution |
| SHW22-75 | Needle Gauge 22 G | In distribution |
| SHG619-100Y | Length 1 in | In distribution |
| SHG20-150Y | Needle Gauge 20 G | In distribution |
| SHG622-150 | Needle Gauge 22 G | In distribution |
| 0652210 | Needle Gauge 22 G | In distribution |
| SHG620-75YS | Needle Gauge 20 G | In distribution |
| 0632234 | Length 0.75 in | In distribution |
| SHG20-75Y | Needle Gauge 20 G | In distribution |
| SHG20-100Y | Needle Gauge 20 G | In distribution |
| SHG19-75Y | Length 0.75 in | In distribution |
| 0681950 | Length 0.5 in | In distribution |
| 0632250 | Needle Gauge 22 G | In distribution |
| LH-0036YN | Length 1.5 in | In distribution |
| SHG22-75YS | Length 0.75 in | In distribution |
| 0642015 | Length 1.5 in | In distribution |
| 0632034 | Length 0.75 in | In distribution |
| LH-0039 | Size = Priming Volume = 0.3 millilitre (mL) | In distribution |
| S02322-50 | Needle Gauge 22 G | In distribution |
| LH-0033YN | Needle Gauge 19 G | In distribution |
| S02320-15 | Length 1.5 in | In distribution |
| SH20-50YS | Needle Gauge 20 G | In distribution |
| S02320-50 | Length 0.5 in | In distribution |
| SHW19-75 | Length 0.75 in | In distribution |
| 0682050 | Needle Gauge 20 G | In distribution |
| 0672215 | Needle Gauge 22 G | In distribution |
| 0132275 | Length 0.75 in | In distribution |
| 581116 | Needle Gauge 19 G | In distribution |
| 012015 | Needle Gauge 20 G | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 529 |
| Codan | Codan US Corp. | 510 |
| Vygon | Vygon Corp. | 355 |
| 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 |
| Alaris | BD Switzerland Sàrl | 122 |
Showing 12 of 768. All products under Set, Administration, Intravascular
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2020-06-19 | Class II | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material | 5,296,132 total | 2022-07-29 |
| Becton, Dickinson & Co. | UDI-DI | 2020-06-19 | Class II | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material | 5,296,132 total | 2022-07-29 |
| Becton, Dickinson & Co. | UDI-DI | 2020-06-19 | Class II | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material | 5,296,132 total | 2022-07-29 |
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.