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Terminated

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.

FDA Recall Z-2890-2016 · Posted 2016-09-27

Recalling FirmEKOS Corporation
Recall StatusTerminated
Product CodeFOX
Date Initiated2016-08-22
Date Terminated2016-12-30
Product Quantity455 units

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.

Firm Action

The firm, EKOS, sent an "URGENT FIELD SAFETY ACTION" letter dated August 22, 2016 to its customers. The letters were sent to customers informing them of the field safety action, how to identify the affected carts at their facility and instructing customers locate the cart, quarantine it and do not use the cart for any procedures. A representative from EKOS Corporation will be contacting customers in the near future to arrange a date and time when the cart at a facility can be inspected and any affected caster(s) replaced. As the cart is inspected, it will be tagged to easily identify it and confirm it has been inspected and repaired as necessary. Customers will be provided with a copy of the inspection/repair form for the cart they inspect. Please retain that form for records. If customers have any questions, please contact EKOS Customer Service at 1-888-400-3567 or your local EKOS representative.

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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