Degania Silicone, Ltd.
Country not established
Site of Degania Silicone Ltd
- Devices
- 0
- FDA recalls
- 43
What Degania Silicone, Ltd. makes
Degania Silicone, Ltd. manufactures low-profile gastrostomy tube/button kits designed for long-term enteral feeding and medication administration in patients requiring gastrostomy access.
These devices are classified as Class IIb under EU regulations and are listed in the eudamed database. The company is based in Israel.
Company details
- Other identifier
- 7682
- Address
- KIBBUTZ, DEGANIA BET Northern
FDA recalls
FDA recall records list 43 recalls initiated by DEGANIA SILICONE, LTD., the earliest on 2017-01-31 and the most recent on 2019-12-02. By recorded status: 43 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 2
- 2018 32
- 2019 9
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 2 Dec 2019 Z-0809-2020 Class II Terminated Temperature deviation did not meet release specifications
- 28 Jun 2019 Z-2260-2019 Class II Terminated 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
- 28 Jun 2019 Z-2261-2019 Class II Terminated 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
- 28 Jun 2019 Z-2262-2019 Class II Terminated 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
- 28 Jun 2019 Z-2263-2019 Class II Terminated 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
- 28 Jun 2019 Z-2264-2019 Class II Terminated 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
- 28 Jun 2019 Z-2265-2019 Class II Terminated 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
- 28 Jun 2019 Z-2266-2019 Class II Terminated 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
- 28 Jun 2019 Z-2267-2019 Class II Terminated 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
2018
- 21 Jun 2018 Z-2754-2018 Class II Terminated 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.
Full distribution text
- 21 Jun 2018 Z-2754-2018 Class II Terminated 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.
Show the 25 most recent of 43 recalls
2018
- 21 Jun 2018 Z-2755-2018 Class II Terminated 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.
Full distribution text
- 21 Jun 2018 Z-2756-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2757-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2758-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2759-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2760-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2761-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2762-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2763-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2764-2018 Class II Terminated 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.
Full distribution text
- 21 Jun 2018 Z-2765-2018 Class II Terminated 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.
Full distribution text
- 21 Jun 2018 Z-2766-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2767-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2768-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2769-2018 Class II Terminated 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.
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- 21 Jun 2018 Z-2755-2018 Class II Terminated 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.