3 results · 11ms · Sources: EU EUDAMED, US FDA

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Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1241, Cat Nos.: 201-124, 202-455, 203-340, 203-674, and 400-872, 2" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1251, Cat Nos.: 201-138, 202-276, 202-456, 203-336, 203-680, and 400-879, 3" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1381, Cat Nos.: 201-126, 203-678, and 400-856, 2" x 3.5" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1501, Cat Nos.: 201-150 and 400-863, 1.25" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1521, Cat No. 400-852, 3 x 5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1541, Cat Nos.:201-154 and 400-865 1.5 x 2.5 Oval Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Cutaneous electrode.

FDA Enforcement
Class II ·Terminated·NAImco Inc dba Richmar Inc·February 20, 2013

Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1241, Cat Nos.: 201-124, 202-455, 203-340, 203-674, and 400-872, 2" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1251, Cat Nos.: 201-138, 202-276, 202-456, 203-336, 203-680, and 400-879, 3" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1381, Cat Nos.: 201-126, 203-678, and 400-856, 2" x 3.5" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1501, Cat Nos.: 201-150 and 400-863, 1.25" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1521, Cat No. 400-852, 3 x 5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-1541, Cat Nos.:201-154 and 400-865 1.5 x 2.5 Oval Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Cutaneous electrode.

FDA Recall
Terminated ·NAImco Inc dba Richmar Inc·Product code GXY·November 30, 2009

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020