Home / Recalls / Degania Medical Devices Pvt. Ltd. / Z-1779-2020

Z-1779-2020 Class II Terminated

Recalled by Degania Medical Devices Pvt. Ltd. — Gurgaon, N/A

Recall Details

Product Type
Devices
Report Date
April 29, 2020
Initiation Date
March 17, 2020
Termination Date
October 25, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2500

Product Description

Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - 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 Pattern

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

Code Information

Lot Numbers: S18013318 S18010936 S19006220 S19006221 S19006222 S19006349

Other recalls by Degania Medical Devices Pvt. Ltd.

  • Z-1782-2020 Class II — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - P (March 17, 2020)
  • Z-1783-2020 Class II — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - P (March 17, 2020)
  • Z-1780-2020 Class II — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - P (March 17, 2020)
  • Z-1787-2020 Class II — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - P (March 17, 2020)
  • Z-1786-2020 Class II — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - P (March 17, 2020)
  • Z-1784-2020 Class II — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - P (March 17, 2020)
  • Z-1789-2020 Class II — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - P (March 17, 2020)
  • Z-1781-2020 Class II — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - P (March 17, 2020)
  • Z-1788-2020 Class II — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - P (March 17, 2020)
  • Z-1785-2020 Class II — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - P (March 17, 2020)