Drug recall
400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile…
FDA recall event 80747 · Class II · COVIDIEN LLC
Key facts
| Event ID | 80747 |
|---|---|
| Recall numbers | Z-3203-2018, Z-3204-2018, Z-3205-2018, Z-3206-2018, Z-3207-2018, Z-3208-2018 |
| Recalling firm | COVIDIEN LLC |
| Product type | Devices |
| Products | 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD, 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD, 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD, P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS, P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient. |
| Initiation date | Jul 11, 2018 |
| Report date | Sep 26, 2018 |
| Termination date | Aug 3, 2020 |
| City | Mansfield |
| State | MA |
| Country | United States |
| FEI number | 1282497 |
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: