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.
Z-2458-2024
Product summary
- Event
- Event 94896
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26,400 units
- Official record key
device-enforcement:Z-2458-2024
Official wording
Reason: Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Code information: Lot # 4127714/ UDI-DI: 00382903825332
Distribution pattern: US: IL OUS: N/A0
Derived failure modes
-
Unknown
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.