BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathen...

FDA Device Recall #Z-1808-2025 — Class II — April 21, 2025

Recall Summary

Recall Number Z-1808-2025
Classification Class II — Moderate risk
Date Initiated April 21, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Becton Dickinson Infusion Therapy Systems, Inc.
Location Sandy, UT
Product Type Devices
Quantity 262,800

Product Description

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

Reason for Recall

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.

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.

Lot / 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

Other Recalls from Becton Dickinson Infusion Therapy Sys...

Recall # Classification Product Date
Z-2007-2025 Class II REF: 381434 BD Insyte Autoguard Shielded IV ... May 21, 2025
Z-2006-2025 Class II REF: 381923 BD Insyte Autoguard Winged Shiel... May 21, 2025
Z-2005-2025 Class II REF: 382544 BD Insyte Autoguard Shielded IV ... May 21, 2025
Z-2002-2025 Class II REF: 381433, BD Insyte Autoguard Shielded IV Ca... May 21, 2025
Z-1999-2025 Class II REF: 381423, BD Insyte Autoguard, Shielded IV C... May 21, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.