DeRoyal Industries Inc: Medical Device Recall in 2014 - (Recall #: Z-2125-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala

Product Classification:

Class II

Date Initiated: June 4, 2014

Date Posted: August 6, 2014

Recall Number: Z-2125-2014

Event ID: 68744

Reason for Recall:

The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.

Status: Terminated

Product Quantity: 230 units

Code Information:

Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541

Distribution Pattern:

Distributed in the states of MI, GA, OH, IL, MO, and IN.

Voluntary or Mandated:

Voluntary: Firm initiated