Temperature Sensing 100% Silicone Foley Catheter recall
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - 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: V18007422 V18010291 V18023106 V18023107 V18023108 V18023109 V18025115 V18025117 V18025118 V18025119 V18026073 V18037032 V18026072 V18035228 V18035229 V18036131 V18037031 V18037033 V18037938 V19001678 V19001679 V19002478 V19002479 V19002480 V19013333 V19025876 V19026564 V19027234 V19027235 V19016726
- Product
- Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure…
- Recalling firm
- Degania Medical Devices Pvt. Ltd.
- Quantity
- 52566
- 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)