FDA recall Z-1992-2020

Covidien Llc · Class II · device

Product

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.

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

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2020-04-30
Report date
2020-05-20
Termination date
2023-12-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1992-2020