Z-2125-2014Class II

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

Name: Z-2125-2014 DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made...
Creator: DeRoyal Industries Inc
Published: 2014-06-04
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2014-06-04 / Terminated / root cause: packaging

FDA source

DeRoyal Industries Inc began a recall of DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala on 2014-06-04. FDA classified it as Class II and gives the reason as "The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2125-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-04
Posted: 2014-07-29
Terminated: 2015-05-05
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
Product code: LRO General Surgery Tray
Reason for recall: The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: The recall was initiated by letter delivered via UPS on 6/4/2014. The firm requested that the consignee contact Stericycle to arrange for return and replacement of the product. A second notice was sent on 7/22/2014 to those accounts who did not respond to the initial notice. Distributors were requested to notify their end-users or provide a list of end-users to DeRoyal for direct notification. Effectiveness checks will be sent via email for those customers who have provided an email contact and via UPS for those customers who have not responded.
Quantity in commerce: 230 units
Distribution: Distributed in the states of MI, GA, OH, IL, MO, and IN.
Product codes and lots: Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2125-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2124-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-29
Z-2125-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-29

Product code LRO

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)