Drug recall
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a…
FDA recall event 74610 · Class III · C.R. Bard, Inc.
Key facts
| Event ID | 74610 |
|---|---|
| Recall numbers | Z-2333-2016 |
| Recalling firm | C.R. Bard, Inc. |
| Product type | Devices |
| Products | SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling problem |
| Initiation date | Jun 29, 2016 |
| Report date | Aug 10, 2016 |
| Termination date | Dec 5, 2017 |
| City | Covington |
| State | GA |
| Country | United States |
| FEI number | 1018233 |
At a glance
- 1–9 Products in this recall
- 10–99 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: