Drug recall
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a…
FDA recall event 78377 · Class II · Resource Optimization & Innovation Llc
Key facts
| Event ID | 78377 |
|---|---|
| Recall numbers | Z-0169-2018 |
| Recalling firm | Resource Optimization & Innovation Llc |
| Product type | Devices |
| Products | Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect label on 3ml ChloraPrep With Tint, Product Code (REF) 260415NS, NDC 054365-400-11, Lot 7096622. The… |
| Initiation date | Sep 25, 2017 |
| Report date | Nov 29, 2017 |
| City | Springfield |
| State | MO |
| Country | United States |
| FEI number | 3004513970 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: