DeRoyal Cardiac Hypothermia Tray — Class II medical device recall Z-2125-2014
Terminated recall by DeRoyal Industries Inc, reported 2014-08-06, distributed in GA, IL, IN, MI, MO, OH. The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira
| Recall number | Z-2125-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2014-06-04 |
| Classified | 2014-07-29 |
| Reported by FDA | 2014-08-06 |
| Terminated | 2015-05-05 |
| Distributed | GA, IL, IN, MI, MO, OH |
| Quantity | 230 units |
| Lot numbers | 30375680, 30515347, 30927691, 32922641, 33656541 |
| Model numbers | 50-9422.07 |
Product
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
Reason for recall
The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2125-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.