Zenysis Dual Lumen Acute Dialysis Catheter
Zenysis DL, 20cm ST Tray w/ GuardIVa
1manufacturer
16catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Baihe Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | MPB |
| Device type | Catheter, Hemodialysis, Non-Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-02-11 |
| Record revised | 2024-09-26 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 5, box of 10 |
| Sizes | Length 12.5 to 24 cm; catheter gauge 11 Fr |
| Distribution end date | 2023-08-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A863120 | Length 12.5 cm | Withdrawn |
| A865200 | Catheter Gauge 11 Fr | Withdrawn |
| A855200G | Length 20 cm | Withdrawn |
| A865150G | Catheter Gauge 11 Fr | Withdrawn |
| A853240 | Length 24 cm | Withdrawn |
| A863200 | Catheter Gauge 11 Fr | Withdrawn |
| A863240 | Catheter Gauge 11 Fr | Withdrawn |
| A855150 | Catheter Gauge 11 Fr | Withdrawn |
| A855240 | Length 24 cm | Withdrawn |
| A853150 | Length 15 cm | Withdrawn |
| A863150 | Length 15 cm | Withdrawn |
| A865120 | Length 12.5 cm | Withdrawn |
| A865240 | Length 24 cm | Withdrawn |
| A855200 | Length 20 cm | Withdrawn |
| A865150 | Length 15 cm | Withdrawn |
| A853200 | Length 20 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 376 |
| Mahurkar Elite | Mozarc Medical US LLC | 119 |
| DUO-Flow® | Medical Components Inc | 106 |
| 400XL | Medical Components Inc | 95 |
| DUO-Split® | Medical Components Inc | 69 |
| Soft-Line® Duo-Flow® | Medical Components Inc | 58 |
| Mahurkar | Mozarc Medical US LLC | 48 |
| Disposable Hemodialysis Access Catheter Set | Guangdong Baihe Medical Technology Co., Ltd. | 38 |
| Disposable Hemodialysis Access Catheter Set Double Lumen14F*16cm(Straight) | Guangdong Baihe Medical Technology Co., Ltd. | 31 |
| Turbo-Flo HD | Cook Incorporated | 28 |
| Duoglide | Bard Access Systems, Inc. | 24 |
| Niagara catheter | Bard Access Systems, Inc. | 23 |
Showing 12 of 59. All products under Catheter, Hemodialysis, Non-Implanted
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-08-10 | Not classified | Material/Component Contamination | this is a downstream recall of class I recall RES 98777 | 149521 | |
| 2026-08-10 | Not classified | Material/Component Contamination | this is a downstream recall of class I recall RES 98777 | 22,980 | |
| 2007-08-10 | Not classified | Other | Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end. | 7225 units | 2008-04-25 |
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.