FDA Device recall Z-3205-2018
400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
- FDA Device
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD by Covidien, citing the temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3205-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-11 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien |
| Distribution | CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA |
Product
400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
Reason
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Identifiers
| code_info | 1733152764 1806451564 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3205-2018%22
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