Recalls / —

—#212498

Product

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

FDA product code

FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K111236, K182870, K213085

Affected lot / code info

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

Why it was recalled

Increased risk for valve housing detachment causing leakage.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

B Braun Medical Inc

Address

824 12th Ave, Bethlehem, Pennsylvania 18018-3524

Distribution

Distribution pattern

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

Timeline

Recall initiated

2025-02-17

Posted by FDA

2025-03-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #212498. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.