FDA recall Z-1780-2020

Product

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

Reason for recall

Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.

Distribution

Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.

Key facts

Status

Terminated

Initiation date

2020-03-17

Report date

2020-04-29

Termination date

2024-10-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurgaon, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1780-2020