Drug recall
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M…
FDA recall event 81889 · Class II · Bard Medical Division
Key facts
| Event ID | 81889 |
|---|---|
| Recall numbers | Z-0803-2019 |
| Recalling firm | Bard Medical Division |
| Product type | Devices |
| Products | SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | potential for urine leakage around the vent on the vented sample port |
| Initiation date | Dec 13, 2018 |
| Report date | Feb 13, 2019 |
| Termination date | Nov 2, 2020 |
| 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: