Covidien Llc: Medical Device Recall in 2020 - (Recall #: Z-1990-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 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: P4P16TSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.

Product Classification:

Class II

Date Initiated: April 30, 2020

Date Posted: May 20, 2020

Recall Number: Z-1990-2020

Event ID: 85629

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

Status: Terminated

Product Quantity: 23587 units

Code Information:

Lot Numbers: 1826714264, 1908533364, 1909302964, 1909303064, 1910654864, 1911300664, 1916240464, 1921106564, 1922533864, 2004908564, 2005617264, 2006339564

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated