PlainRecalls
FDA Devices Moderate Class II Terminated

Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - 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-1994-2020

Product Description

Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - 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
0
Distribution
US Nationwide distribution.
Location
Mansfield, MA

Frequently Asked Questions

What product was recalled? ▼
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.. Recalled by Covidien Llc. Units affected: 0.
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-1994-2020.

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