Temperature Sensing 100% Silicone Foley Catheter recall
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
Why was Temperature Sensing 100% Silicone Foley Catheter recalled?
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: V18022049 V18022050 V18026085 V18026084 V18034279 V18052058 V18052059 V18052880 V19000868
- Product
- Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
- Recalling firm
- Degania Medical Devices Pvt. Ltd.
- Quantity
- 11267
- Distribution
- Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
- Recall date
- April 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)