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Degania Silicone Recalls
43 recalls on record · March 1, 2017 to January 22, 2020 · Medical Devices
Recalls by year
17
18
19
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 26, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, s
Hazard: 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.
September 26, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is sterile, si
Hazard: 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.
September 26, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-wa
Hazard: 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.
September 26, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-wa
Hazard: 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.
September 26, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-wa
Hazard: 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.
September 26, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-wa
Hazard: 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.
September 26, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-wa
Hazard: 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.
September 26, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way
Hazard: 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.
September 26, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile, single use,
Hazard: 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.
September 26, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, t
Hazard: 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.
September 26, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use,
Hazard: 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.
March 14, 2018Medical DevicesFDA
Degania Silicone, Ltd. recalls Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of bo
Hazard: Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
March 1, 2017Medical DevicesFDA
Degania Silicone, Ltd. recalls Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health,
Hazard: Product sterility compromised due to breach of sterile barrier