FDA Device recall Z-1619-2017
Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
- FDA Device
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa 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-1619-2017 |
| 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: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
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 | 027750A Exp Date 2017-08-24; 028676A Exp Date 2017-10-13; 029916A Exp Date 2017-12-08; 030661A Exp Date 2018-01-04; 034835A Exp Date 2018-07-11; |
|---|
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-1619-2017%22
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