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Recall Observatory FDA recall evidence

Device product

BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862

Z-1808-2025

April 21, 2025

Class II

Product summary

Firm
Becton Dickinson Infusion Therapy Systems, Inc.
Event
Event 96696
Status
Ongoing
Classification
Class II
Quantity
262,800
Official record key
device-enforcement:Z-1808-2025

Official wording

Reason: Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.

Code information: REF/UDI-DI/Lot/Expiration: 386865/0100382903868650/4198480/30-Jun-2027, 386803/0100382903868032/4247809/31-Aug-2027, 386862/0100382903868629/4237744/31-Aug-2027

Distribution pattern: Worldwide - US Nationwide distribution in the states of IN, AL, CA, FL, TX, NJ, MO, NC, NY, OH, AZ, MN, MA, WA, OK, KS, MS, LA, MD, GA, TN, NM, PA and the country of CA.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing defect