FDAClass IIMay 26, 2021

REF 7655405 recall

REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when…

Why was REF 7655405 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot No. reds2369 reds3369 reds4464 reds4588 redt0655 redt0787 redt1710 redt1760 redt2668 redt2909 redt4286 redt4309 redu0080 redu0745 redu0826 redu0827 redu1375 redu1533 redu2186 redu2403 redu2995 redu3073 redu3829 redu3920 redv1130 redv1285 REDV2022 redv2095 redv2812 redv2886 redv3944 REDV4092 REDW0350 REDW0460 redw1019 redw1151 redw1668 redw1669 redw1695 redw2471 redw2592 redw3754 redx0981 redx0982 redx0984 redx0985 redx0986 redx0987 redx1000 redx1001 REDX1002 redx1003 redx4676 redy0095 redy0096 redy0108 redy0109 redy0644 redy0703 REDZ0125 redz0433 redz1593 redz2836 redz3691 redz3692 redz3694 reen1167 reen1970 reen1971 reen3067 reen3286 reen4660 reen4733 reen5319 reep0814 reep1710 reeq2360 reeq2384 reeq2507 reeq2508 REDX3652 redy3370 REEQ2519

Product
REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when…
Recalling firm
Bard Access Systems Inc.
Quantity
N/A
Distribution
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.
Recall date
May 26, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls