FDA Device recall Z-2125-2014
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc
- FDA Device
- Class II
- terminated
- Published 2014-08-06
On 2014-08-06 the FDA classified a Class II recall of DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc by Deroyal Industries, citing the firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2125-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-04 |
| Published | 2014-08-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Deroyal Industries |
| Distribution | GA, IL, IN, MI, MO, OH |
Product
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
Reason
The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
Identifiers
| code_info | Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2125-2014%22
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