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.
- 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 :
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Part Number
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Lot Numbers
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3373
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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
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3393
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38995, 33994, 39788, 40082, 40568, 40569, 40674, 40994, 41325, 41326, 41749, 41931, 44536, 44534, 44535, 44533
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3173-98
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48072
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3173-14
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38638, 38940, 39139, 39318, 39418, 39480, 39744, 39947, 43620, 43893, 45730, 46483, 46658, 46799, 47927, 48073
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3165-98
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3165-95
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38592, 38992, 39210, 39743, 39886, 40627, 40953, 41121, 41560, 41882, 43504, 43619, 45251, 45827, 45919, 46657, 47598
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3372
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38941, 39213, 40203, 41694, 42317, 42700, 43129, 43195, 43502, 44695, 45065, 45254, 45919, 46776, 47369, 4669149785.
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3383-95
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43895, 45117, 47953, 48895
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3344-95
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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
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3353-95
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40981, 42106, 45561, 48288, 49258
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3363-95S
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43406, 43607, 44030, 44062, 44264, 44327, 44422, 44863, 44981, 45262, 46124, 46886, 46585, 47077, 47312, 48831.
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3363-95
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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
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3373-98
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47652, 48352
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3362-95
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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
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3373-95
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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
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3372-95
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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
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3342-95
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39212, 38783, 40566, 40636, 40865, 41823, 42380, 43753, 45317, 46270, 46355, 47310, 49450, 49716
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