FDA Device recall Z-1658-2021
REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075…
- FDA Device
- Class II
- terminated
- Published 2021-05-26
On 2021-05-26 the FDA classified a Class II recall of REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075… 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-1658-2021 |
| 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 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - 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. redr1671 reds4453 redt1612 redt2758 redt3914 redu0326 redu3286 redu3402 redu4194 redu4226 redv1248 r…Lot No. redr1671 reds4453 redt1612 redt2758 redt3914 redu0326 redu3286 redu3402 redu4194 redu4226 redv1248 redv2001 redv2750 redw0124 redx3813 redx3828 redy1863 redy2874 redy3867 redz0552 redz1927 redz3505 REEN1390 reen1396 reeq1509 reet2730 reet3239 reeu0563 reew2029 reex2346 reex3092 reey2704 reex3917 |
|---|
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-1658-2021%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.