Becton Dickinson Infusion Therapy Systems, Inc.: Device Recall

Recall #Z-2458-2024 · 06/26/2024

Class II: Risk

Recall Details

Recall Number: Z-2458-2024
Classification: Class II
Product Type: Device
Recalling Firm: Becton Dickinson Infusion Therapy Systems, Inc.
Status: Ongoing
Date Initiated: 06/26/2024
Location: Sandy, UT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 26,400 units

Reason for Recall

Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.

Product Description

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.

Distribution Pattern

US: IL OUS: N/A0

Other Recalls by Becton Dickinson Infusion Therapy Systems, Inc.

Class II: Risk 05/21/2025

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Class II: Risk 05/21/2025

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Class II: Risk 05/21/2025

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Class II: Risk 05/21/2025

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Class II: Risk 05/21/2025

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

View all recalls by Becton Dickinson Infusion Therapy Systems, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.