Recall Z-1669-2021— Bard Access Systems Inc.

Name: FDA recall Z-1669-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-07

Class II · Terminated

Class II FDA medical device recall by Bard Access Systems Inc., initiated 2021-04-07, terminated 2023-06-01. It names 2 FDA 510(k) clearances: K201452, K063240. Product: REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - 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.

Recalling firm: Bard Access Systems Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-04-07
Terminated: 2023-06-01
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

2 on FDA's record

K201452 — Groshong NXT PICC CatheterC.R. Bard, Inc.·cleared 2021-03-12
K063240 — SHERLOCK TLS STYLET, SHERLOCK TLS DETECTORC.R. Bard, Inc.·cleared 2006-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when central venous catheterization is prescribed.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.