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Recall Observatory FDA recall evidence

Device product

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

Z-1397-2025

February 17, 2025

Class II

Product summary

Firm
B Braun Medical Inc
Event
Event 96293
Status
Ongoing
Classification
Class II
Quantity
28,200 units
Official record key
device-enforcement:Z-1397-2025

Official wording

Reason: Increased risk for valve housing detachment causing leakage.

Code information: Model No 4251128-02; UDI-DI 04046964014017; Lot 24F09G8952.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Increased risk for valve housing detachment causing leakage.