FDA Enforcement
Class II
Terminated
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.
Recall: Z-1988-2020
·
Reported May 20, 2020
Enforcement
- Recall Number
- Z-1988-2020
- Event ID
- 85629
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Covidien Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 20, 2020
- Initiation Date
- April 30, 2020
- Classification Date
- May 14, 2020
- Termination Date
- December 14, 2023
- Address
- 15 Hampshire St, N/A, Mansfield, MA, 02048-1113, United States
Description
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
Code Info
Lot Numbers: 1909308464, 1933000164
Distribution
US Nationwide distribution.
Quantity
3470 units