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U.S. Department of Health and Human Services

Class 2 Device Recall Groshong NXT ClearVue Catheter

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  Class 2 Device Recall Groshong NXT ClearVue Catheter see related information
Date Initiated by Firm April 07, 2021
Create Date May 20, 2021
Recall Status1 Terminated 3 on June 01, 2023
Recall Number Z-1661-2021
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 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036009 - Product Usage: is designed for use when central venous catheterization is prescribed.
Code Information Lot No. reep1720 redy0653 REEN1127 REEN1905 reeq0634 rees0249 reet2073 reev1213 reew4243  
Recalling Firm/
Bard Access Systems Inc.
605 N 5600 W
Salt Lake City UT 84116-3738
For Additional Information Contact Customer/Technical Support
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 2
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.