Z-2458-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2024
- Initiation Date
- June 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,400 units
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.
Reason for Recall
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Distribution Pattern
US: IL OUS: N/A0
Code Information
Lot # 4127714/ UDI-DI: 00382903825332