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U.S. Department of Health and Human Services

Class 2 Device Recall Hamilton Soft Grip Pipettes, 1 ml adjustable volume

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  Class 2 Device Recall Hamilton Soft Grip Pipettes, 1 ml adjustable volume see related information
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
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
For Additional Information Contact
775-858-3000 Ext. 236
Manufacturer Reason
for Recall		 Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity
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
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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