Introcan Safety 3 Closed IV Catheter 22 Ga — Class II medical device recall Z-1397-2025
Ongoing recall by B Braun Medical Inc, reported 2025-03-26, distributed in CA, FL, GA, IL, IN, MD, MN, MO…. Increased risk for valve housing detachment causing leakage.
| Recall number | Z-1397-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical Inc, Bethlehem, PA, United States |
| Recall initiated | 2025-02-17 |
| Classified | 2025-03-19 |
| Reported by FDA | 2025-03-26 |
| Distributed | CA, FL, GA, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, WA |
| Countries outside the US | CA |
| Quantity | 28,200 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 04046964014017 |
| Lot numbers | 24F09G8952 |
| Model numbers | 4251128-02 |
Product
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Reason for recall
Increased risk for valve housing detachment causing leakage.
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-1397-2025. 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.