FDA (Devices) recall action 83287

Degania Silicone, Ltd. recalled 8 products on 2019-08-21

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2019-08-21
Critical: 0
Units: 25,860

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

SevereFDA (Devices)··2019-08-21
Smith & Nephew Wound Drain Recall Due to Breakage Risk
Smith & Nephew is recalling 15FR and 19FR channel wound drains because they may break during use or removal, requiring additional surgery.
Product
Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 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 flu
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0 states
SevereFDA (Devices)··2019-08-21
Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 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,
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0 states
SevereFDA (Devices)··2019-08-21
Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
Degania Silicone is recalling 2,160 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, potentially requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 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 bloo
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0 states
SevereFDA (Devices)··2019-08-21
Cardinal Health Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 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, dr
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0 states
SevereFDA (Devices)··2019-08-21
Degania Silicone Recalls Jackson-Pratt Channel Drains Due to Breakage Risk
Degania Silicone is recalling Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery to remove the broken end.
Product
Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 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 blo
Category
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0 states
SevereFDA (Devices)··2019-08-21
Medline Silicone Drain Recalled for Risk of Breaking During Use
Degania Silicone is recalling 200 units of Medline Silicone Drains because they may break during use, requiring additional surgery to remove the broken end.
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 cavi
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0 states
SevereFDA (Devices)··2019-08-21
Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling 640 units of Jackson-Pratt Channel Drains because they may break during use or removal, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 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 b
Category
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0 states
SevereFDA (Devices)··2019-08-21
Degania Silicone Jackson-Pratt Channel Drain Recall for Breakage Risk
Degania Silicone is recalling 6,080 units of Cardinal Health Jackson-Pratt Channel Drains because they may break during use, requiring additional surgery.
Product
Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 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 blo
Category
Distribution
0 states