FDA Device recall Z-2799-2015
Regard Custom Surgical Pack, Item Number: 800208002
- FDA Device
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of Regard Custom Surgical Pack, Item Number: 800208002 by Resource Optimization And Innovation, citing surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2799-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-19 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Resource Optimization And Innovation |
| Distribution | LA, SC |
Product
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Reason
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
Identifiers
| code_info | 025072B |
|---|
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-2799-2015%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.