Peripheral Catheter Insertion Kit
Sldgr IDC, 20gx10cm, Full w/o Guardiva
1manufacturer
20catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | PND |
| Device type | Midline Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-06-22 |
| Record revised | 2024-01-08 (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 |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 10, case of 5 |
| Sizes | Length 8 to 10 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ST018101D | Length 10 cm | In distribution |
| ST018080 | Gauge | In distribution |
| ST222081 | Gauge | In distribution |
| ST020081D | Length 8 cm | In distribution |
| ST118081 | Gauge | In distribution |
| ST220101 | Gauge | In distribution |
| ST120101 | Length 10 cm | In distribution |
| ST020080 | Length 8 cm | In distribution |
| ST020100 | Gauge | In distribution |
| ST022080 | Gauge | In distribution |
| ST122081 | Length 8 cm | In distribution |
| ST120081 | Gauge | In distribution |
| ST218101 | Length 10 cm | In distribution |
| ST018100 | Gauge | In distribution |
| ST218081 | Gauge | In distribution |
| ST022081D | Gauge | In distribution |
| ST220081 | Gauge | In distribution |
| ST020101D | Gauge | In distribution |
| ST118101 | Gauge | In distribution |
| ST018081D | Gauge | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midline Catheter Kit | Bard Access Systems, Inc. | 68 |
| PowerMidline | Bard Access Systems, Inc. | 57 |
| Vygon | Vygon Corp. | 36 |
| Arrow | Teleflex Medical LLC | 33 |
| Provena Midline | Bard Access Systems, Inc. | 31 |
| primeMIDLINE | PFM Medical, Inc | 6 |
| Provena | Bard Access Systems, Inc. | 5 |
| BioFlo | Navilyst Medical, Inc. | 4 |
| PowerGlide ST | Bard Access Systems, Inc. | 3 |
| CT Midline Catheter | Medical Components Inc | 3 |
| 20G 8CM Stiletto Extended Dwell Catheter | Avia Vascular | 1 |
| Arch-FLO CT Midlinearch-FLO CT Midline | Medical Components Inc | 1 |
Showing 12 of 14. All products under Midline Catheter
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | UDI-DI | 2020-03-17 | Class II | Packaging change control | Iincorrectly packaged without the required lidocaine as labeled | 655 kits | 2020-10-21 |
Recalls
3 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 |
|---|---|---|---|---|
| 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. | 24,348 |
| 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. | 16,887 |
| 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. | 2,844 |
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.