Reported Apr 29, 2020 · Terminated
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone…
Degania Medical Devices Pvt. Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Degania Medical Devices Pvt. Ltd. · Plot No 251 · Gurgaon, N/A · N/A
Is this the product you have?
- Temperature Sensing 100% Silicone Foley Catheter, Part
- Number 102201101463MD - Product Usageis a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder
- Lot codes and dates
- Lot Numbers
V18022033V18025110V18025111V18029225V18029226V19024273V19013327V19025875V19016720V19025874
- Lot Numbers
- Amount recalled
- 16393
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
- IL
Why it was recalled
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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