PlainRecalls
FDA Devices Moderate Class II Terminated

Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16XTSD - 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-1991-2020

Product Description

Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16XTSD - 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
46828 units
Distribution
US Nationwide distribution.
Location
Mansfield, MA

Frequently Asked Questions

What product was recalled? ▼
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.. Recalled by Covidien Llc. Units affected: 46828 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-1991-2020.

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