Bard Access Systems Inc. REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036016 - Product Usage: is designed for use when central venous catheterization is prescribed. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.