The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart ...

FDA Device Recall #Z-2890-2016 — Class II — August 22, 2016

Recall Summary

Recall Number Z-2890-2016
Classification Class II — Moderate risk
Date Initiated August 22, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm EKOS Corporation
Location Bothell, WA
Product Type Devices
Quantity 455 units

Product Description

The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.

Reason for Recall

Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.

Distribution Pattern

US Nationwide Distribution in states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY.

Lot / Code Information

Lot numbers: 030915 032615 040915 061515 071515 081715 103015 120715 010416 011816 022216 032116 052416

Other Recalls from EKOS Corporation

Recall # Classification Product Date
Z-2854-2016 Class II EkoSonic Endovascular Devices EKOS Intellige... Aug 9, 2016
Z-0864-2016 Class II EkoSonic Endovascular System, Catalog Number 50... Jan 21, 2016
Z-2148-2015 Class II The EKOS EkoSonic Control Unit is intended excl... Jun 24, 2015
Z-0133-2014 Class II The EkoSonic Endovascular System employs high f... Oct 2, 2013
Z-2023-2012 Class II EkoSonic MACH4 Endovascular Device (Catalog #50... May 24, 2012

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.