BD Insyte Autoguard BC — Class II medical device recall Z-2458-2024
Ongoing recall by Becton Dickinson Infusion Therapy Systems, Inc., reported 2024-08-07, distributed in IL. Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion proces
| Recall number | Z-2458-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT, United States |
| Recall initiated | 2024-06-26 |
| Classified | 2024-07-31 |
| Reported by FDA | 2024-08-07 |
| Distributed | IL |
| Quantity | 26,400 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00382903825332 |
| Lot numbers | 4127714 |
| Model numbers | 1.00, 382533 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2458-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.