Recall Z-2458-2024— Becton Dickinson Infusion Therapy Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson Infusion Therapy Systems, Inc., initiated 2024-06-26. It names one FDA 510(k) clearance: K201075. 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: Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process..
- Recalling firm
- Becton Dickinson Infusion Therapy Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-26
- Firm location
- Sandy, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.