FDA Enforcement
Class II
Ongoing
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.
Recall: Z-2458-2024
·
Reported August 7, 2024
Enforcement
- Recall Number
- Z-2458-2024
- Event ID
- 94896
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Becton Dickinson Infusion Therapy Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 7, 2024
- Initiation Date
- June 26, 2024
- Classification Date
- July 31, 2024
- Address
- 9450 S State St, N/A, Sandy, UT, 84070-3213, United States
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.
Reason
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Code Info
Lot # 4127714/ UDI-DI: 00382903825332
Distribution
US: IL OUS: N/A0
Quantity
26,400 units