FDA Device recall Z-2007-2025
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly by Becton Dickinson Infusion Therapy Systems, citing due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2007-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-21 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson Infusion Therapy Systems |
| Distribution | US |
Product
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Reason
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Identifiers
| code_info | Lot# 4116814/ UDI: 00382903814343 |
|---|
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-2007-2025%22
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