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

FDA device recall Z-2125-2014 · posted 2014-07-29 · Terminated

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

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

Action taken

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.

Root cause

Packaging change control

Status

Terminated

Product code

LRO

Quantity affected

230 units

Distribution

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

Date initiated

2014-06-04

Date posted

2014-07-29

Date terminated

2015-05-05

Location

Powell, TN