FDA Device recall Z-1988-2020
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer…
- FDA Device
- Class II
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer… by Covidien, citing temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1988-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-30 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Covidien |
| Distribution | US |
Product
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P14TSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Reason
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Identifiers
| code_info | Lot Numbers: 1909308464, 1933000164 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1988-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.