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.
Reported: April 29, 2020 Initiated: March 17, 2020 #Z-1780-2020
Product Description
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.
Details
- Recalling Firm
- Degania Medical Devices Pvt. Ltd.
- Units Affected
- 1929
- Distribution
- Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
- Location
- Gurgaon, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Degania Medical Devices Pvt. Ltd.. Units affected: 1929.
Why was this product recalled? ▼
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2020. Severity: Moderate. Recall number: Z-1780-2020.
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