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Open, Classified

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

FDA Recall Z-1397-2025 · Posted 2025-03-19

Recalling FirmB Braun Medical Inc
Recall StatusOpen, Classified
Product CodeFOZ
Date Initiated2025-02-17
Product Quantity28,200 units

Reason for Recall

Increased risk for valve housing detachment causing leakage.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213085Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. · 2021-10-25K182870Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. · 2019-03-07K111236INTROCAN 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 1B.Braun Melsungen AG · 2011-08-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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