EZKClass II
Catheter, Retention Type
Gastroenterology, Urology · 21 CFR 876.5980
MDR events11All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances3All time
Recent MDR events
11 adverse event reports on file
- LUBRI-SILSep 1, 2016MalfunctionC.r. Bard, Inc.5920472
- LUBRI-SILSep 1, 2016MalfunctionC.r. Bard, Inc.5920477
- ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SETMar 11, 2011MalfunctionCook, Inc.1820334-2011-00120
- ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SETNov 10, 2010DeathCook Inc1820334-2010-00552
- ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SETJun 26, 2009MalfunctionCook, Inc.1820334-2009-00356
- ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SETJan 14, 2009InjuryCook Inc.1820334-2009-00012
- WILLS-OGLESBY GASTROSTOMY CATHETERDec 13, 2007MalfunctionCook, Inc.1820334-2007-00489
- MALECOT RUSSEL GASTROSTOMY CATHETERNov 11, 2005MalfunctionCook, Inc.1820334-2005-00296
- MALECOT RUSSEL GASTROSTOMY CATHETEROct 22, 2003OtherCook, Inc.1820334-2003-00185
- PYRAMESHSep 8, 1998InjurySofamor Danek Mfg.1030489-1998-00070
Event type breakdown
Malfunction6
Injury3
Death1
Other1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code