3 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis, MN 55432-5604. (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Affected products are SynchroMed II Model 8637 pumps with batteries (MECC Lifetest Batteries) manufactured from April 9, 2002 through July 2, 2002 (internally defined as Time Period 1), and from August 15, 2003 to March 16, 2005 (internally defined as Time Period 3). The SvnchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the certain drugs and fluids.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·July 1, 2009
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·November 23, 2016
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·November 23, 2016