Degania Silicone, Ltd.
KIBBUTZ, DEGANIA BET Northern, IL
Registered product codes
22 product codes
Recent MDR events
87 on file
- MEDI LOOPMay 15, 2024Malfunction8030107-2024-00002
- MON A THERM FOLEY CATHETER WITH TEMPERATURE SENSORMay 1, 2024Malfunction8030107-2024-00001
- JP CHANNEL DRAIN 10MM, FULL FLUTESOct 18, 2023Injury1423537-2023-00997
- FLUTED ROUND DRAIN10FR (HUB) TROCAR & CONNECTORNov 2, 2022Malfunction8030107-2022-00005
- JP CHANNEL DRAIN SILICONE HUBLESS 15FRMay 29, 2022Malfunction8030107-2022-00003
- EXUFLOW ROUND 15FR 3/4(HUB)TROCAR P.STER.May 29, 2022Malfunction8030107-2022-00004
- FLUTED F.D 10MM WHITE (HUB) STERILEFeb 20, 2022Malfunction8030107-2022-00001
- FLUTED F.D 10MM WHITE (HUB) STERILEFeb 20, 2022Malfunction8030107-2022-00002
- EXUFLOW FLAT FULL DUCT 10MMJan 24, 2022Malfunction8030107-2021-00012
- EXUFLOW FLAT FULL DUCT 10MMOct 20, 2021Malfunction8030107-2021-00011
Recalls
43 on file
- TerminatedFeb 20, 2018
Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
View FDA record ↗ - TerminatedFeb 22, 2017
Product sterility compromised due to breach of sterile barrier
View FDA record ↗ - TerminatedUnknown
Temperature deviation did not meet release specifications
View FDA record ↗ - TerminatedUnknown
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
View FDA record ↗ - TerminatedUnknown
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
View FDA record ↗ - TerminatedUnknown
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
View FDA record ↗ - TerminatedUnknown
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
View FDA record ↗ - TerminatedUnknown
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
View FDA record ↗ - TerminatedUnknown
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
View FDA record ↗ - TerminatedUnknown
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
View FDA record ↗
Compliance history
Matched by FEI 7682.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.