PlainRecalls
FDA Devices Moderate 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.

Reported: August 7, 2024 Initiated: June 26, 2024 #Z-2458-2024

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.

Details

Units Affected
26,400 units
Distribution
US: IL OUS: N/A0
Location
Sandy, UT

Frequently Asked Questions

What product was recalled?
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.. Recalled by Becton Dickinson Infusion Therapy Systems, Inc.. Units affected: 26,400 units.
Why was this product recalled?
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 7, 2024. Severity: Moderate. Recall number: Z-2458-2024.