Degania Silicone, Ltd. Recall: Temperature sensor Foley catheter 10FR, Catalogue Number 10
Degania Silicone, Ltd. Recall: Temperature sensor Foley catheter 10FR, Catalogue Number 10 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Degania Silicone, Ltd.; Product: Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile, single use
| Recalling firm | Degania Silicone, Ltd. |
|---|---|
| Product | Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB 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. |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico. |
| Recall initiated | 20180621 |
| Recall number | Z-2756-2018 |
| Category | device |
| State | N/A |
| Country | Israel |
$29/mo
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