FDA (Devices) recall action 73024

Xeridiem Mediem Medical Devices Inc recalled 105 products on 2016-03-02

The FDA (Devices) publishes a recall like this one as 105 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 105 pages.

Products: 105
Announced: 2016-03-02
Critical: 0
Units: 7,209

Why these products were recalled

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

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.

States named across these recalls

51–75 of 105

HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage of feeding solution or gastric contents.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc. is recalling 34 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD P/N 70-0050-924) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
SevereFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548270 (XMD P/N 70-0050-612) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 31 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549370 (XMD P/N 70-0050-722) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549540 (XMD P/N 70-0050-A24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc. is recalling 32 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549460 (XMD P/N 70-0050-G22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548500 (XMD P/N 70-0050-116) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 243 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 38 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549550 (XMD P/N 70-0050-B24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548790 (XMD P/N 70-0050-E18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing feeding solution or gastric contents to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549560 (XMD P/N 70-0050-C24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
SevereFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 34 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents when disconnected.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices Inc. is recalling 36 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548290 (XMD P/N 70-0050-812) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 77 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548690 (XMD P/N 70-0050-418) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
SevereFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 326 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548740 (XMD P/N 70-0050-918) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548390 (XMD P/N 70-0050-614) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-0050-F24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem Mediem Medical Devices is recalling 38 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548970 (XMD P/N 70-0050-G20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548860 (XMD P/N 70-0050-520) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 205 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548380 (XMD P/N 70-0050-514) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548310 (XMD P/N 70-0050-A12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state
HighFDA (Devices)··2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 91 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548570 (XMD P/N 70-0050-816) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The End
Category
Distribution
1 state