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Class 2 Device Recall Hamilton Soft Grip Pipettes, 1 ml adjustable volume |
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Date Initiated by Firm |
May 07, 2008 |
Date Posted |
September 17, 2008 |
Recall Status1 |
Terminated 3 on February 08, 2011 |
Recall Number |
Z-2233-2008 |
Recall Event ID |
48425 |
Product Classification |
Pipette - Product Code JQW
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Product |
Hamilton Soft Grip Pipettes, 1 ml adjustable volume, model number 55019-40 Product is indicated for manual pipetting. |
Code Information |
Serial numbers 63045, 63098, 63135, 63157, 63208, 63248, 63278, 63378, 63401, 63418, 63421, 63442, 63461, 63485, 63524, 63527, 63590, 63679, 63753, 63788, 63804, 63820, 63825, 63834, 63836, 63848, 63857, 63885, 63892, 63904, 63951, 63989, 63993, 64047, 64057, 64074, 64076, 64093, 64140, 64160, 64242, 64246, 64261, 64279, 64288, 64289, 64314, 64342, 64352, 64362, 64399, 64407, 64427, 64478, 64479, 64480, 64492, 64498, 64504, 64507, 64518, 64520, 64525, 64527, 64528, 64537, 64538, 64543, 64544, 64563, 64577, 64582, 64585, 64587, 64590, 64592, 64599, 64612, 64628, 64631, 64635, 64636, 64644, 64667, 64678, 64694, 64695, 64703, 64706, 64718, 64720, 64722, 64723, 64729, 64740, 64753
64757, 64759, 64760, 64763, 64767, 64772, 64778, 64785, 64787, 64789, 64792, 64797, 64801, 64810, 65015, 65016, 65018, 65067, 65068, 65071, 65076, 65078, 65079, 65080, 65083, 65090, 65091, 65109, 65119, 65186, 65204, 65224, 65262, 65269, 65290, 65514, 65536, 65541, 65564, 65566, 65567, 65568, 65575, 65576, 65578, 65583, 65590, 65591, 65597, 65600, 65603, 65608, 65609, 65610, 65612, 65614, 65617, 65622, 65623, 65626, 65628, 65631, 65632, 65635, 65644, 65650, 65655, 65657, 65662, 65678, 65692, 65701, 65705, 65707, 65726, 65747, 65771, 65772, 65773, 65777, 65836, 65858, 65906, 65910, 65916, 65917, 65918, 65921, 65925, 65926, 65927, 65929, 65930, 65933, 65935, 65936, 65938, 65946, 65947, 65952, 65953, 65959, 65961, 65964, 65966, 65973, 65979, 65981, 65982, 65983, 65987, 65993, 65995, 65996, 65997, 65998, 65999, 66000, 66002, 66007, 66008, 66013, 66014, 66015, 66016, 66017, 66019, 66062, 66079, 66088, 66104, 66107, 66115, 66124, 66138, 66145, 66174, 66182, 66196, 66197, 66198, 66201, 66205, 66210, 66222, 66226, 66233, 66252, 66253, 66270, 66286, 66289, 66296, 66305, 66309, 66341, 66342, 66345, 66351, 66353, 66361, 66366, 66372, 66373, 66380, 66397, 66398, 66400, 66402, 66403, 66404, 66417, 66418, 66422, 66423, 66425, 66426, 66431, 66434, 66436, 66438, 66443, 66444, 66448, 66450, 66452, 66453, 66456, 66463, 66465, 66474, 66475, 66480, 66483, 66484, 66488, 66490, 66496, 66497, 66503, 66504, 66505, 66512, 66517, 66519, 66520, 66522, 66523, 66534, 66535, 66538, 66540, 66548, 66549, 66550, 66552, 66555, 66556, 66557, 66558, 66560, 66562, 66565, 66567, 66568, 66569, 66573, 66574, 66576, 66577, 66578, 66582, 66584, 66591, 66601, 66603, 66605, 66607, and 66612 |
Recalling Firm/ Manufacturer |
Hamilton Co 4970 Energy Way Reno NV 89502-4123
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For Additional Information Contact |
775-858-3000 Ext. 236
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Manufacturer Reason for Recall |
Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity
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FDA Determined Cause 2 |
Device Design |
Action |
Recall initiated May 7 2008. Notification issued via certified overnight mail explains the problem and instructs customers to inventory the affected pipettes. The firm will contact its customers and supply replacement lower-body assemblies, repair instructions and return information so that affected parts can be returned to Hamilton. A fax-back form is supplied with each notification. Responses will be tracked. Contact Hamilton Co. at 1-775-558-3000 for assistance. |
Quantity in Commerce |
305 units |
Distribution |
Product distributed throughout the US and to Puerto Rico, New Zealand, Australia, Japan and Canada. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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