Covidien Llc: Medical Device Recall in 2020 - (Recall #: Z-1992-2020)

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 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 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.

Product Classification:

Class II

Date Initiated: April 30, 2020

Date Posted: May 20, 2020

Recall Number: Z-1992-2020

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: 46828 units

Code Information:

Lot Numbers: 1828206564, 1828813264 1829618264, 1829618364 1831001964, 1906506564 1907134164, 1909308864 1919705064, 1921106664 2000723764, 2003520164 2005617664

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated