Foley Catheter with temperature sensor 400TM 12FR recall
Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, single use, two-way silicone Foley…
Why was Foley Catheter with temperature sensor 400TM 12FR recalled?
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
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?
S17000808, S17000943, S17000946, S17002077, S17001347, S17002197, S17002979, S17003351, S17003439, S17003347, S17003350, S17004190, S17004479, S17004736, S17000809, S17000660, S17001348, S17001349, S17005948, S17005949
- Product
- Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, single use, two-way silicone Foley…
- Recalling firm
- Degania Silicone, Ltd.
- Quantity
- 47520
- Distribution
- Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
- Recall date
- September 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)