Reported Sep 26, 2018 · Terminated
Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY 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 16FR, Catalogue
- Number 102201101680TY 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
S17002091S17002440S17001607S17002441S17002558S17002559S17002561S17002562S17002563S17002681S17003391S17004379S17002560S17002682S17003456S17003219S17003301S17003302S17004772S17004376S17004377S17004378S17005117S17005029S17005281S17005983S17006720S17004509S17004510S17004511S17004771S17004902S17005028S17005030S17005529S17005984S17005985S17004380S17005979S17006723S17005980S17005981S17005982S17005986S17006718S17006719S17006721S17006722S17006724S17006725S17007360S17007459S17007622S17002986S17006363S17007623S17002987S17007806S17008017S17002090
- Amount recalled
- 92150
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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