Degania Medical Devices Pvt. Ltd.: Medical Device Recall in 2020 - (Recall #: Z-1787-2020)

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:

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

Product Classification:

Class II

Date Initiated: March 17, 2020
Date Posted: April 29, 2020
Recall Number: Z-1787-2020
Event ID: 85327
Reason for Recall:

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

Status: Terminated
Product Quantity: 9137
Code Information:

Lot Numbers: V18031235 V18050229 V18050230 V18050231 V18050232 V18050233 V19027860 V19028470 V19018929

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated