Skip to content
Recall Observatory FDA recall evidence

Device product

REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for use when central venous catheterization is prescribed.

Z-1657-2021

April 07, 2021

Class II

Product summary

Firm
Bard Access Systems Inc.
Event
Event 87594
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1657-2021

Official wording

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

Code information: Lot No. redv2820 redv4093 redw0517 redw1152 redx1436 redx2421 redx4735 redy0645 redy3049 redz0252 redz0603 redz1577 redz2772 reen1196 reen2065 reen3257 reen4734 reep0839 reep1691 reeq0592 reeq1318 reeq2347 reer0515 reer1136 reer3474 rees0504 rees1461 rees2183 rees3127 reet0308 reet0816 reet2299 reeu0258 reeu1473 REEU2662 reeu3582 reev0163 reev1198 reew2878 reew3089 reew4300 reex2176 reez2355 reex3435

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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