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Recall Observatory FDA recall evidence

Device product

REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for use when central venous catheterization is prescribed.

Z-1653-2021

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-1653-2021

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. reds3422, redt4228, redu0707, redu1364, redv1255, redv2161, redv2786, redv4057, redw0433, redw1225, redw2664, redw3833, redx2372, redx4194, redy0664, redy1758, redz0057, redz0666, redz1930, reen1132, reen3294, reen4671, reep0758, reep1721, reep2923, reep3974, reeq0638, rees0525, rees0590, reew2481, reew2485, reew2487,

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