FIHClass IILife-sustaining
Pump, Infusion Or Syringe, Extra-luminal
Gastroenterology, Urology · 21 CFR 876.5820
MDR events140All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances5All time
Recent MDR events
140 adverse event reports on file
- GRASEBY¿ 2000 SYRINGE PUMP RANGEJul 3, 2018MalfunctionSmiths Medical Asd, Inc.3012307300-2018-02581
- ALARIS PCSep 19, 2012MalfunctionCardinal Health2759727
- PERCUPUMP ARTICULATING ARM MOUNTING ACCESSORYMar 23, 2007MalfunctionMavig2411512-2007-00003
- MEDFUSION 2001I SYRINGE INFUSION PUMPDec 1, 2006MalfunctionSmiths Medical Md2183502-2006-00176
- MEDFUSION 2001I SYRINGE INFUSION PUMPDec 1, 2006MalfunctionSmiths Medical Md, Inc.2183502-2006-00175
- MEDFUSION 2001I SYRINGE INFUSION PUMPOct 6, 2006MalfunctionSmiths Medical Md2183502-2006-00114
- PERCUPUMP TOUCHSCREEN INJECTOR W/EDAApr 13, 2006MalfunctionE-z-em, Inc.2411512-2006-00001
- PERCUPUMP TOUCHSCREEN INJECTOR W/ EDAFeb 18, 2005MalfunctionE-z-em, Inc.2411512-2005-00004
- PERCUPUMP TOUCHSCREEN INJECTOR W/EDAFeb 17, 2005MalfunctionE-z-em, Inc.2411512-2005-00003
- PLUNGER HOLDER/TRACK IIDec 9, 2004MalfunctionMedex1036813-2004-00092
Event type breakdown
Malfunction118
Injury9
Unspecified7
Other4
Death2
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
510(k) clearances
5 clearances for this product code
- E-Z-Em, Inc.Mar 21, 1995
K932055 · PERCUPUMP II
- Infusion Technology Intl.Apr 28, 1994
K935461 · VECTOR AMBULATORY DRUG DELIVERY SYSTEM
- Pharmacia Deltec, Inc.Apr 28, 1994
K931113 · CADD-TPN(TM) AMBULATORY INFUSION SYSTEM
- L H M Ent., Inc.Feb 15, 1990
K900439 · SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC
- B&B Medical Assoc., Inc.Oct 21, 1988
K881707 · INTROCULAR FLUID INJECTOR