B Braun Medical Inc recalls Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in.

Increased risk for valve housing detachment causing leakage.

Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.

An URGENT MEDICAL DEVICE RECALL NOTIFICATION dated 2/13/25 was mailed to consignees notifying them of this product removal. Consignees are instructed to review the recall notification and to forward the notice along to those in their organization and to those to which product was further distributed. Consignees are to quarantine any affected devices in their inventory and coordinate product return by completion and return of the provided Product Recall Acknowledgement Form. Consignees with any questions are to contact B Braun at 844-903-6417.

• FDA enforcement recordOfficial FDA database entry for Z-1397-2025
• FDA 510(k) clearance · K111236The device's official FDA premarket clearance record
• FDA 510(k) clearance · K182870The device's official FDA premarket clearance record
• FDA 510(k) clearance · K213085The device's official FDA premarket clearance record
• FDA device classification · FOZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find B Braun Medical IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.