FDAFDA · Food and drugs·Recall number Z-2458-2024
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.
Published August 7, 2024 · Recall initiated: June 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson Infusion Therapy Systems, Inc.
- Distributor
- US: IL OUS: N/A0
- Lot
- Lot # 4127714/ UDI-DI: 00382903825332
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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