FDA Device recall Z-1667-2021

REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 279…

FDA Device
Class II
terminated
Published 2021-05-26

On 2021-05-26 the FDA classified a Class II recall of REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 279… 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-1667-2021
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 CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - 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. redz3509 REEN4546 reep4145 reer0944 reer2048 rees1328 rees2108 rees3222 reeu1443 reeu2740 reeu3561 reew4312

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-1667-2021%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.