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Terminated

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

FDA Recall Z-2125-2014 · Posted 2014-07-29

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2014-06-04
Date Terminated2015-05-05
Product Quantity230 units

Reason for Recall

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

Firm 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.

Root Cause

Packaging change control

Distribution Pattern

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

Official Source

View FDA Recall →

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

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