Drug recall
regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit containing cover light handle…
FDA recall event 71904 · Class II · Resource Optimization & Innovation Llc
Key facts
| Event ID | 71904 |
|---|---|
| Recall numbers | Z-0028-2016, Z-0029-2016, Z-0030-2016, Z-0031-2016, Z-0032-2016, Z-0033-2016, Z-0034-2016, Z-0035-2016, Z-0036-2016, Z-0037-2016, Z-0038-2016, Z-0039-2016 and 65 more |
| Recalling firm | Resource Optimization & Innovation Llc |
| Product type | Devices |
| Products | regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure…, regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure…, regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray…, regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray…, regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains… and 72 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The kits contain an equipment glove component which may contain splits or holes compromising the sterility. |
| Initiation date | Apr 22, 2015 |
| Report date | Oct 14, 2015 |
| Termination date | Mar 28, 2017 |
| City | Springfield |
| State | MO |
| Country | United States |
| FEI number | 3004513970 |
At a glance
- 10–99 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: