CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
Foley Catheter with temperature sensor 400TM recalled
Degania Silicone is recalling Foley Catheter with temperature sensor 400TM, distributed nationwide in the US. The recall was initiated on 21 Jun 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2764-2018
- FDA event ID
- 80641
- Recalling firm
- Degania Silicone, Dganya Bet, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2018
- FDA classified
- 20 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Heart & Vascular Devices
Timeline
| 21 Jun 2018 | Recall initiated by company | |
| 20 Sep 2018 | Classified by FDA | +91 days |
| 26 Sep 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This 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.
Where it was distributed
Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
Questions about this recall
Why was it 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.
Which lots are affected?
S17000808, S17000943, S17000946, S17002077, S17001347, S17002197, S17002979, S17003351, S17003439, S17003347, S17003350, S17004190, S17004479, S17004736, S17000809, S17000660, S17001348, S17001349, S17005948, S17005949
Where was it sold?
Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
31 other products · FDA event 80641This product is part of a recall event; the main page for the event is Foley Catheter with temperature sensor 400TM recalled.
More recalls from Degania Silicone
All 43| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Thermistor Foley Catheter 5-, non sterile recalled | Degania Silicone | Temperature Abuse | IL |
| Device | CLASS II | Medline Silicone Drain 3/16" Full Fluted PN recalled by Degania Silicone | Degania Silicone | Device Malfunction | Nationwide |
| Device | CLASS II | Cardinal Health Jackson-Pratt Channel Drain recalled by Degania Silicone | Degania Silicone | Device Malfunction | Nationwide |
| Device | CLASS II | Cardinal Health Jackson-Pratt Channel Drain recalled by Degania Silicone | Degania Silicone | Device Malfunction | Nationwide |
| Device | CLASS II | Cardinal Health Jackson-Pratt Channel Drain, Full flutes recalled | Degania Silicone | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |