تجاوز إلى المحتوى الرئيسي

Saudi Food and Drug Authority alerts from using alcohol prep pads under trade name "TRIAD“

2013-01-26

 
 
 
 
 
Saudi Food and Drug Authority would like to alert healthcare practitioners and Infection control departments from using alcohol prep pads under trade name " TRIAD “ which exist in some affected Lot numbers ( See below ) of Pulset Arterial Blood Gas (ABG) sampling kit manufactured by Westmed Inc.
Westmed is recalling some Lot numbers of Pulset Arterial Blood Gas (ABG) sampling kits that contains an alcohol pads under trade name " TRIAD “  due to potential contaminants with objectionable organism that might cause Rash or skin infection.
 
Saudi Food and Drug Authority recommends all healthcare practitioners to adhere to the following

 

Remove " TRIAD" alcohol prep pad from the Arterial Blood Gas (ABG) sampling kits and dispose of the alcohol prep pad only.
Use an iodine pads which is also available with the kit for sample site preparation
Identify the effected product by the part No. and Lot No. as well as attached images.
Distribution and dissemination of information contained in this warning to all concerned.

 
 

For further information please
                                                
Saudi Food and Drug Authority encourage all  to report any adverse event associated with medical devices through the National Center for Medical Devices Reporting :
 

 

 
Part Number
  
Lot Numbers
3373
38813, 38634, 39148, 39946, 40951, 40952, 41593, 41740, 42914, 43291, 43999, 45252, 46341, 46653, 47175, 47371, 48029, 48266, 48351, 48495, 48661, 48897, 49145, 49236, 49325, 49408, 49522, 49718, 49966
3393
38995, 33994, 39788, 40082, 40568, 40569, 40674, 40994, 41325, 41326, 41749, 41931, 44536, 44534, 44535, 44533
3173-98
48072
3173-14
38638, 38940, 39139, 39318, 39418, 39480, 39744, 39947, 43620, 43893, 45730, 46483, 46658, 46799, 47927, 48073
3165-98
 
3165-95
38592, 38992, 39210, 39743, 39886, 40627, 40953, 41121, 41560, 41882, 43504, 43619, 45251, 45827, 45919, 46657, 47598
3372
38941, 39213, 40203, 41694, 42317, 42700, 43129, 43195, 43502, 44695, 45065, 45254, 45919, 46776, 47369, 4669149785.
3383-95
43895, 45117, 47953, 48895
3344-95
33814, 39481, 39786, 40083, 40333, 41338, 41642, 41885, 42318, 43129, 43606, 44063, 45116, 45765, 45898, 46358, 46905, 47313, 47595, 48153, 48155, 48154, 48156, 48348, 48624, 49000, 49097, 49100, 49099, 49098, 49102, 49101, 49257, 49841
3353-95
40981, 42106, 45561, 48288, 49258
3363-95S
43406, 43607, 44030, 44062, 44264, 44327, 44422, 44863, 44981, 45262, 46124, 46886, 46585, 47077, 47312, 48831.
3363-95
38637, 38915, 39143, 39147, 39146, 39392, 39745, 39746, 39747, 39748, 40014, 40226, 40225, 40224, 40223, 40565, 40910, 40567, 40955, 41086, 41087, 41317, 41413, 41412, 41414, 41592, 41973, 42071, 42171, 42321, 42595, 42319, 43180, 43130, 43405,43618, 43751, 44064, 44104, 44145, 44384, 44566, 44835, 45057, 45058, 45257, 45255, 45256, 45366, 45669, 45766, 45882, 46108, 46108, 46122, 46339, 46469, 46777, 46655, 46974, 47080, 47226, 47314, 47434, 47596, 47651, 47747, 47746, 48157, 48221, 48483, 48579, 48507, 48623, 48622, 48482, 48762, 48810, 48971, 48927, 49096, 49182, 49259, 49301, 49304, 49303, 49305, 49451, 49586, 49786, 49842
3373-98
47652, 48352
3362-95
39560, 39833, 40185, 40201, 40332, 40983, 41027, 41253, 41693, 41884, 42224, 42592, 42977, 43290, 43373, 43564, 43670, 43752, 44143, 44333, 44677, 44752, 45212, 45559, 45560, 45699, 46107, 46356, 46271, 46654, 46923, 47078, 47218, 47774, 48288, 48143
3373-95
38784, 39142, 39144, 39145, 39211, 39137, 39141, 39322, 39321, 39629, 39628, 39630, 39830, 39831, 39832, 40424, 40625, 40950, 41402, 41415, 42070, 42416, 42517, 42858, 43325, 43196, 43577, 43982, 44146, 44678, 45562, 45671, 45826, 46340, 46470, 46780, 46779, 47081, 47174, 47370,47487, 47597, 47606, 47847, 48484, 48580, 48625, 48811, 48860, 48896, 49036, 49260, 49357, 49473, 49569, 49906
3372-95
38747, 40202, 40423, 40728, 41028, 43127, 44144, 44383, 44648, 44862, 45253, 45825, 46357, 46775, 47079, 47607, 47773, 47733, 48350, 48220, 48809, 48894, 49035, 49095, 49181, 49256, 49326, 49356, 49568, 49717, 49905, 50935
3342-95
39212, 38783, 40566, 40636, 40865, 41823, 42380, 43753, 45317, 46270, 46355, 47310, 49450, 49716