RecallDepth

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

Company
B Braun Medical Inc
Recall Initiated
February 17, 2025
Posted
March 19, 2025
Recall Number
Z-1397-2025
Quantity
28,200 units
Firm Location
Bethlehem, PA

Reason for Recall

Increased risk for valve housing detachment causing leakage.

Distribution

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

Lot / Code Info

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

Root Cause

Process control

Action Taken

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.

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