FDA Device recall Z-1654-2021
REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for us…
- FDA Device
- Class II
- terminated
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class II recall of REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for us… by Bard Access Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1654-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-07 |
| Published | 2021-05-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bard Access Systems |
| Distribution | US |
Product
REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for use when central venous catheterization is prescribed.
Reason
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 inability to properly lock
Identifiers
| code_info | Lot No. REDY1755 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1654-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.