FDA Device recall 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
- FDA Device
- Class II
- ongoing
- Published 2024-08-07
On 2024-08-07 the FDA classified a Class II recall of 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 by Becton Dickinson Infusion Therapy Systems, citing catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2458-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-26 |
| Published | 2024-08-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson Infusion Therapy Systems |
| Distribution | IL |
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.
Identifiers
| code_info | Lot # 4127714/ UDI-DI: 00382903825332 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2458-2024%22
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