FDAJune 28, 2019device
Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certa...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
degania siliconedegania
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCBazic Products Recalls Bazic Silicone Glue Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child Resistant Packaging and FHSA Labeling Requirements2026-01-29
- CPSCZippee Silicone Activity Toys Recalled Due to Risk of Serious Injury or Death from Choking; Violates Mandatory Standard for Toys; Imported by Mobi Games2025-11-13
- CPSCChews Life Recalls Silicone Rosary and Decade Teethers Due to Choking Hazard2025-03-13
- CPSCMelii Baby Silicone Spoons for Babies Recalled Due to Choking Hazard; Imported by Melii Baby2024-12-19
- CPSCSilicone Baby Toy Bear Activity Toys Recalled Due to Laceration Hazard; Manufactured by Konges Sløjd Denmark A/S2022-07-21
- CPSCMushie & Co Recalls FRIGG Silicone Pacifiers Due to Choking Hazard2022-01-19
- FDATemperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.2020-03-17
- FDATemperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.2020-03-17
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