Recall archive / FDA device enforcement
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) ... — FDA record Z-2458-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 26, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Becton Dickinson Infusion Therapy Systems, Inc.
- Quantity
- 26,400 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2458-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # 4127714/ UDI-DI: 00382903825332 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: IL OUS: N/A0
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 7, 2024
- Recall initiation date
- Jun 26, 2024
- Center classification date
- Jul 31, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.