—#128592

Product

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

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541

Why it was recalled

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

Root cause (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

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

Timeline

Recall initiated: 2014-06-04
Posted by FDA: 2014-07-29
Terminated: 2015-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128592. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.