Device product
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
Z-2125-2014
Product summary
- Event
- Event 68744
- Status
- Terminated
- Classification
- Class II
- Quantity
- 230 units
- Official record key
device-enforcement:Z-2125-2014
Official wording
Reason: The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
Code information: Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541
Distribution pattern: Distributed in the states of MI, GA, OH, IL, MO, and IN.
Derived failure modes
-
Unknown
The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.