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Degania Silicone, Ltd. recalls Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that
Recalled August 21, 2019 · FDA recall Z-2266-2019 · Degania Silicone
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 · FDA Class II
Units
200
Sold at
Nationwide Distribution
Description
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
Product
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 certain physiologic conditions.
Manufacturer(s)
Degania Silicone, Ltd.
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →