Reported Sep 26, 2018 · Terminated
Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile,…
Degania Silicone, 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 Silicone, Ltd. · Degania Bet · Dganya Bet, N/A · N/A
Is this the product you have?
- Foley Catheter with temperature sensor 400TM 12FR, Catalogue
- Number 102201101280TY Product UsageThis is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period
- Lot codes and dates
S17000808S17000943S17000946S17002077S17001347S17002197S17002979S17003351S17003439S17003347S17003350S17004190S17004479S17004736S17000809S17000660S17001348S17001349S17005948S17005949
- Amount recalled
- 47520
This recall covers 32 products
The agency filed one notice per product. You are reading one of them; the other 31 are below.
19 more are in the archive.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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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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