DeRoyal THE RESOURCE GROUP — Class II medical device recall Z-1981-2019
Terminated recall by DeRoyal Industries Inc, reported 2019-07-24. Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalle
| Recall number | Z-1981-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2019-06-18 |
| Classified | 2019-07-16 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2020-09-16 |
| Quantity | 108 units |
| Reason classes | sterility |
| Lot numbers | 49888830 |
| Model numbers | 89-9211.07 |
Product
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Reason for recall
Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.
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-1981-2019. 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.