Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Reported: May 20, 2020 Initiated: April 30, 2020 #Z-1984-2020
Product Description
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Reason for Recall
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
Details
- Recalling Firm
- Covidien Llc
- Units Affected
- 468 units
- Distribution
- US Nationwide distribution.
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.. Recalled by Covidien Llc. Units affected: 468 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2020. Severity: Moderate. Recall number: Z-1984-2020.
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