FDA Device recall Z-1649-2017
Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn
- FDA Device
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn by Resource Optimization And Innovation, citing custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the steril….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1649-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-09 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Resource Optimization And Innovation |
| Distribution | LA, TX |
Product
Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn
Reason
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Identifiers
| code_info | 037464C Exp Date 2018-04-30; 038804C Exp Date 2018-04-30; 040546C Exp Date 2018-10-31 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1649-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.