Z-2890-2016Class II

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

Name: Z-2890-2016 The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold...
Creator: EKOS Corporation
Published: 2016-08-22
License: https://open.fda.gov/license/

EKOS Corporation / initiated 2016-08-22 / Terminated / root cause: design

FDA source

EKOS Corporation began a recall of 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... on 2016-08-22. FDA classified it as Class II and gives the reason as "Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2890-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-22
Posted: 2016-09-27
Terminated: 2016-12-30
Recalling firm: EKOS Corporation
Product: 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.
Product code: FOX Stand, Infusion
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 455 units
Distribution: 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.
Product codes and lots: Lot numbers: 030915 032615 040915 061515 071515 081715 103015 120715 010416 011816 022216 032116 052416

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2890-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2890-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-27

Product code FOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)