Class 2 Device Recall Groshong NXT ClearVue Catheter

• Date Initiated by Firm: April 07, 2021
• Create Date: May 20, 2021
• Recall Status: Terminated on June 01, 2023
• Recall Number: Z-1656-2021
• Recall Event ID: 87594
• 510(K)Number: K201452 K063240
• Product Classification: Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
• Product: REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when central venous catheterization is prescribed.
• Code Information: 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
• Recalling Firm/ Manufacturer: Bard Access Systems Inc.; 605 N 5600 W; Salt Lake City UT 84116-3738
• For Additional Information Contact: Customer/Technical Support; 844-823-5433
• Manufacturer 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
• FDA Determined Cause: Process control
• Action: On April 7, 2021, Bard Access Systems issued a "Urgent Medical Device Recall - Correction" to affected consignees via FedEx. In addition to informing consignees about the correction, the firm ask consignees to take the following actions: 1. Share this correction notification with all users within your facility network of the product to ensure they are also aware of this recall and shipment of no charge connectors. 2. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements. Note: There is no need to discard or return product to BD. If the clinician encounters the issue described in this notification, obtain a Replacement Connector (REF# 7812400, Groshong nXt, 4Fr Connector Repair Kit). If the Replacement Connector is not available at your facility, then obtain the connector from a new 4Fr S/L Groshong nXt catheter kit. 3. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 4. If you require further assistance, please contact: Customer/technical Support @ 1-844-823-5433, Mon-Fri: 8:30 AM - 5:00 PM CST. For customers outside US, contact your local BD representative or distributor.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LJS and Original Applicant = C.R. BARD, INC.