NKKClass II
Needle, Hypodermic, Single Lumen, Reprocessed
General Hospital · 21 CFR 880.5570
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
MDR events7All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
7 adverse event reports on file
- ULTRA FLOWAug 4, 2025MalfunctionAlcon Laboratories, Inc.22698159
- MONOJECT LIFESHIELDOct 25, 2019MalfunctionCovidien Llc9238700
- SAFETY NEEDLEJun 25, 2017MalfunctionCovidien1017768-2017-05094
- DRAGONFLY IMAGING CATHETERSep 19, 2012InjurySt. Jude Medical3004672267-2012-00006
- DRAGONFLY IMAGING CATHETERAug 7, 2012InjurySt. Jude Medical3004672267-2012-00005
- DRAGONFLY IMAGING CATHETERJun 25, 2012InjurySt. Jude Medical3004672267-2012-00004
- QUIXIL APPLICATION DEVICEDec 3, 2009DeathOmrix Biopharmaceuticals Ltd.3003183625-2009-00078
Event type breakdown
Injury3
Malfunction3
Death1
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Deformation Due to Compressive Stress1
Device Contamination with Chemical or Other Material1
Device Operates Differently Than Expected1
Failure to Advance1
Improper or Incorrect Procedure or Method1
Material Fragmentation1
Material Twisted/Bent1
Physical Resistance1
Trend for “Deformation Due to Compressive Stress”
No history to chart.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.