FDA Device recall Z-1397-2025
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged by B Braun Medical, citing increased risk for valve housing detachment causing leakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1397-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-17 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | B Braun Medical |
| Distribution | CA, FL, GA, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, WA |
Product
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Reason
Increased risk for valve housing detachment causing leakage.
Identifiers
| code_info | Model No 4251128-02; UDI-DI 04046964014017; Lot 24F09G8952. |
|---|
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-1397-2025%22
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