FDA recall Z-2458-2024

Becton Dickinson Infusion Therapy Systems, Inc. · Class II · device

Product

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

US: IL OUS: N/A0

Key facts

Status
Ongoing
Initiation date
2024-06-26
Report date
2024-08-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sandy, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2458-2024