B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Produ...

FDA Device Recall #Z-0559-2014 — Class II — September 27, 2013

Recall Summary

Recall Number Z-0559-2014
Classification Class II — Moderate risk
Date Initiated September 27, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm B. Braun Medical, Inc.
Location Allentown, PA
Product Type Devices
Quantity 55,200 units

Product Description

B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into vascular system.

Reason for Recall

One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.

Distribution Pattern

USA Nationwide Distribution including Puerto Rico.

Lot / Code Information

lot no. 3C30258317

Other Recalls from B. Braun Medical, Inc.

Recall # Classification Product Date
Z-1021-2025 Class II Design Options COMBINED SPINAL/EPIDURAL TRAY- ... Dec 4, 2024
Z-3144-2024 Class II AET36 ANESTH EXT SET - Anesthesia Extension Set... Aug 8, 2024
Z-2387-2024 Class II Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-U... Jun 17, 2024
Z-2380-2024 Class II Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE... Jun 17, 2024
Z-2391-2024 Class II Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE... Jun 17, 2024

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.