Recall Z-1397-2025— B Braun Medical Inc
Class II · Ongoing
Class II FDA medical device recall by B Braun Medical Inc, initiated 2025-02-17. It names 3 FDA 510(k) clearances: K213085, K182870, K111236. 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..
- Recalling firm
- B Braun Medical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-17
- Firm location
- Bethlehem, PA, United States
510(k) clearances named in this recall
3 on FDA's record- K213085 — Introcan Safety 3 Closed IV Catheter
- K182870 — Introcan Safety 3 Closed IV Catheter
- K111236 — INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.