Recall Z-2768-2018
Degania Silicone, Ltd. · initiated June 21, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP 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.
Codes / lots: S17000350
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.
FDA-determined cause: Employee error
Action taken
Urgent Field Safety Notice letters were distributed to customers on 6/21/18. The letters instructed customers to perform the following: 1. Please forward this information to the immediate attention of the persons responsible for usage of the affected parts. Sub-recall must be initiated by your company to collect any distributed product from the suspected list. 2. Please fill in the attached Recall Response form and indicate the quantity of the affected product in your possession. 3. Promptly return the completed Recall Response form to Degania Silicone by e-mail: Katia@ds-il.com Any affected product should be returned to Degania Facility at Rhode Island: Degania Silicone, Inc. 14 Thurber Blvd, Suite A Smithfield, RI 02917, US Contact name: Jackie Dubon e-mail: jackie@deganiasilicone.com
Details
- Recall number
- Z-2768-2018
- Initiated
- June 21, 2018
- Terminated
- October 25, 2024
- Product code
- EZL – Catheter, Retention Type, Balloon
- Quantity
- 250
- Distribution
- Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
- Recalling firm
- Degania Silicone, Ltd.
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2754-2018 Class II | Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2755-2018 Class II | Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2756-2018 Class II | Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2757-2018 Class II | Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2758-2018 Class II | Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2759-2018 Class II | Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2760-2018 Class II | Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2761-2018 Class II | Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2762-2018 Class II | Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2763-2018 Class II | Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2764-2018 Class II | Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2765-2018 Class II | Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2766-2018 Class II | Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2767-2018 Class II | Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2769-2018 Class II | Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2770-2018 Class II | Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2771-2018 Class II | Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2772-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2773-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2774-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2775-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2776-2018 Class II | Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2777-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2778-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2779-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2780-2018 Class II | Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage:…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2781-2018 Class II | Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2782-2018 Class II | Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2783-2018 Class II | Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |
| Z-2784-2018 Class II | Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This…The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body… | 06/21/2018Terminated |