Class 2 Device Recall BD Insyte Autoguard Shielded IV Catheter

• Date Initiated by Firm: May 21, 2025
• Date Posted: June 23, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2002-2025
• Recall Event ID: 96865
• 510(K)Number: K201075
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
• Code Information: Lot # 4290664/UDI:382903814336
• Recalling Firm/ Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.; 9450 S State St; Sandy UT 84070-3213
• For Additional Information Contact: BD North American Regional Complaint Center; 1844-823-5433
• Manufacturer Reason for Recall: Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
• FDA Determined Cause: Component design/selection
• Action: On May 21, 2025, Becton Dickinson Infusion Therapy (BD) issued a "Urgent: Medical Device Recall" Notification to affected consignees FedEx and E-Mail. BD asked consignees to take the following actions: 1. Immediately review your inventory for product listed in the above table. Cease use and destroy any unused affected devices. 2. For devices that have deployed and are currently in use or if an impacted device was previously used, no additional follow-up activities are required for patients that have completed therapy. 3. Share and post this Product Recall letter within your facility network and forward to any customers you may have distributed the product to ensure awareness. Ensure the contents of this Product Recall are read and understood by those within your organization. 4. 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.
• Quantity in Commerce: 50 units
• Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FOZ