Degania Medical Devices Pvt. Ltd.: Medical Device Recall in 2020 - (Recall #: Z-1788-2020)

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 102203101663DO - 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-1788-2020

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: 67499

Code Information:

Lot Numbers: V18024145 V18024144 V18027064 V18026042 V18026043 V18026045 V18029205 V18029206 V18037913 V18049310 V19007111 V19007110 V19008666 V19008664 V19009594 V19013277 V19027814 V19027863 V19027865

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated