Class 2 Device Recall Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology

• Date Initiated by Firm: June 26, 2024
• Date Posted: July 31, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2458-2024
• Recall Event ID: 94896
• 510(K)Number: K201075
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
• Code Information: Lot # 4127714/ UDI-DI: 00382903825332
• Recalling Firm/ Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.; 9450 S State St; Sandy UT 84070-3213
• For Additional Information Contact: Product Complaints, Technical Questions; 1844-823-5433
• Manufacturer Reason for Recall: Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
• FDA Determined Cause: Process control
• Action: On June 26, 2024, Becton Dickinson Infusion Therapy Systems Inc. issued a "Urgent: Medical Device Product Recall" Notification to affected consignees via: mail. BD ask consignees to take the following actions: 1. Ensure the contents of this Product Recall communication are read and understood by those within your organization. 2. Immediately review your inventory for Catalog Number 382533, Lot number 4127714. Destroy all unused product subject to the recall following your institution s process for destruction. 3. If affected device was previously used on a patient without incident, no further action is necessary. If the device is currently in use and issue has not been observed, continue to use as normal. 4. Notify any and all entities of this recall to whom the affected product may have been transferred. 5. Complete the attached Customer Response Form and return to your distributor, whether or not you have any of the impacted material.
• Quantity in Commerce: 26,400 units
• Distribution: US: IL OUS: N/A0
• 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