Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
- Company
- Wilson-Cook Medical Inc
- Recall Initiated
- January 4, 2019
- Terminated
- July 21, 2020
- Recall Number
- Z-1132-2019
- Quantity
- 34,456 units
- Firm Location
- Winston Salem, NC
Reason for Recall
Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.
Distribution
Worldwide Distribution: US (nationwide) in the states of: AL, AR, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: ARGENTINA, BRAZIL, CANADA, MEXICO, NETHERLANDS ANTILLES, AUSTRIA, BELARUS, BELGIUM, FINLAND, FRANCE, GERMANY, ITALY, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SLOVAKIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, UNITED ARAB EMIRATES, UNITED KINGDOM, AUSTRALIA, CHINA, INDIA, NEW ZEALAND, TAIWAN, REPUBLIC OF CHINA and THAILAND.
Lot / Code Info
ASDB-15-015- S with Lot #'s W4010785, W4010787, W4010788, W4010789, W4010791, W4010792, W4010793, W4010794, W4010795, W4010796, W4010797, W4010799, W4010801, W4010802, W4010803, W4010804, W4010805, W4010806, W4012291, W4012292, W4012294, W4012295, W4012296, W4012300, W4013231, W4015568, W4015569, W4015570, W4015571, W4015572, W4015574, W4015575, W4015576, W4015577, W4015578, W4018215, W4018216, W4018217, W4018219, W4018220, W4018221, W4018222, W4018223, W4019733, W4019734, W4019735, W4019736, W4019738, W4019739, W4019742, W4019743, W4019744, W4020127, W4020128, W4020129, W4020130, W4020131, W4020132, W4020133, W4020134, W4021578, W4021579, W4021580, W4021581, W4021582, W4021583, W4021584, W4021585, W4021586, W4021587, W4021588, W4021589, W4021591, W4021598, W4023828, W4023835, W4023836, W4023837, W4023838, W4023839, W4023840, W4023841, W4023843, W4023844, W4023845, W4024369, W4024370, W4024371, W4024372, W4024373, W4024374, W4025299, W4025300, W4025301, W4025302, W4025303, W4025304, W4025305, W4025332, W4025337, W4025338, W4025339, W4025342, W4025343, W4025344, W4025345, W4025347, W4025348, W4025349, W4025350, W4025351, W4026852, W4026853, W4026854, W4026861, W4026862, W4026863, W4026864, W4026867, W4026868, W4026869, W4026870, W4026874, W4026875, W4026876, W4028204, W4028207, W4028208, W4028838, W4028840, W4028841, W4028842, W4028843, W4028844, W4028845, W4028846, W4028847, W4028848, W4028849, W4029402, W4029403, W4029404, W4029408, W4029410, W4029411, W4029412, W4029413, W4029414, W4029415, W4029416, W4029417, W4029418, W4029988, W4029989, W4029990, W4029991, W4029993, W4029994, W4029995, W4031839, W4031840, W4031841, W4031842, W4031843, W4031844, W4033749, W4033751, W4033752, W4033755, W4033756, W4033757, W4035185, W4035186, W4035187, W4035188, W4035950, W4035951, W4035952, W4035953, W4035954, W4035955, W4035956, W4035957, W4035958, W4035959, W4035960, W4035961, W4035962, W4036659, W4036661, W4036663, W4036664, W4036665, W4036666, W4036667, W4036824, W4036825, W4036827, W4036828, W4036829, W4036833, W4036834, W4036835, W4036836, W4038384, W4038385, W4038386, W4038387, W4038388, W4038389, W4038390, W4038764, W4038765, W4038766, W4038767, W4039337, W4039338, W4039339, W4039340, W4039341, W4039342, W4039343, W4039344, W4039345, W4039346, W4040557, W4040558, W4040559, W4040560, W4040561, W4041764 W4041768, W4043628, W4044770, W4044771, W4045381, W4045382, W4045383, W4045384, W4045385, W4045386, W4045387, W4045388, W4045389, W4045390, W4047726, W4047727, W4047728, W4048929, W4048930, W4048931, W4048932, W4048933, W4048934, W4048935, W4048936, W4049885, W4049895, W4049896, W4049897, W4051087, W4051093, W4051770, W4051772, W4051773, W4052558, W4052560, W4052561, W4052562, W4053058, W4053059, W4053060, W4053061, W4053062, W4053660, W4053661, W4053662, W4053663, W4053664, W4053665, W4053666, W4053667, W4056455, W4056456, W4056457, W4058230, W4058234, W4058235, W4059450, W4059451, W4059452, W4060209, W4060210, W4060211, W4060213, W4061432, W4061433, W4061434, W4061435, W4061440, W4061441, W4062017, W4062028, W4062029, W4062030, W4062031, W4062032, W4062633, W4062635, W4062636, W4062638, W4063529, W4064384, W4065132, W4065133, W4065134, W4065135, W4065136, W4065137, W4066650, W4066651, W4066658, W4066659, W4066660, W4067360, W4067361, W4067362, W4067895, W4067906, W4067909, W4067910, W4067911, W4068623, W4068625, W4068626, W4068627, W4068628, W4069129, W4069131, W4069132, W4069133, W4069134, W4069139, W4069140, W4070127, W4070128, W4070129, W4070131, W4070132, W4070714, W4070715, W4070717, W4070718, W4070719, W4070720, W4070721, W4070722, W4070723, W4071340, W4071341, W4071342, W4071343, W4071693, W4071694, W4071695, W4071696, W4071697, W4071701, W4071702, W4071703, W4072882, W4072884, W4072885, W4072886, W4072888, W4072889, W4072905, W4075173, W4075174, W4075175, W4075177, W4075178, W4075181, W4075182, W4075183, W4075185, W4076681, W4076682, W4076683, W4076684, W4076685, W4076686, W4076687, W4080002, W4080003, W4080004, W4080005, W4080006, W4080007, W4080008, W4080009, W4080010, W4080011, W4080713, W4080714, W4080715, W4080716, W4080717, W4080718, W4080719, W4080721, W4085548, W4085549, W4085550, W4085554, W4085556, W4085557, W4085558, W4085559, W4085560, W4085561, W4087633, W4087634, W4087635, W4087636, W4087637, W4087638, W4087639, W4087640, W4087641, W4087642, W4087646, W4087647, W4088977, W4088978, W4088979, W4088980, W4088981, W4088982, W4088983, W4088984, W4090948, W4090949, W4090950, W4090951, W4090952, W4090954, W4090955, W4090956, W4090958, W4090959, W4092759, W4092760, W4092763, W4092764, W4092765, W4092766, W4092767, W4095494, W4095495, W4095497, W4095498, W4095502, W4096097, W4096098, W4096099, W4096100, W4096101, W4096102, W4096103, W4096104, W4097782, W4097783, W4097784, W4097785, W4097786, W4097787, W4098209, W4098210, W4098211, W4098212, W4098213, W4098214, W4098215, W4098216, W4098217, W4098218, W4098219, W4098220, W4099939, W4099940, W4099941, W4099942, W4099943, W4099944, W4099945, W4099946, W4099947, W4099948, W4099950, W4099951, W4099952, W4099953, W4099957, W4099958, W4099960, W4099961, W4099962, W4099963, W4099964, W4099965, W4101131, W4101132, W4101133, W4101146, W4101147, W4101148, W4101149, W4101150, W4101151, W4101152, W4101153, W4104061, W4104064, W4104065, W4104067, W4104068, W4104069, W4104072, W4104073, W4104074, W4104076, W4104077, W4104078, W4104079, W4104080, W4104081, W4104919, W4105321, W4105322, W4105325, W4105326, W4105327, W4105328, W4105330, W4105331, W4105332, W4105333, W4105334, W4105335, W4105336, W4105337, W4105338, W4105343, W4105344, W4105867, W4105868, W4105869, W4106539, W4106540, W4106541, W4106545, W4106546, W4106547, W4108503, W4108504, W4108505, W4108508, W4108509, W4108511, W4108512, W4108513, W4109251, W4109253, W4109255, W4109256, W4109257, W4109258, W4109259, W4109260, W4109261, W4110676, W4111693, W4112208, W4112210, W4112211, W4112212, W4112213, W4112215, W4112216, W4112217, W4112218, W4112219, W4112220, W4112469, W4112470, W4112471, W4112472, W4112473, W4114772, W4114773, W4114774, W4114775, W4114776, W4114777, W4115063, W4115067, W4115068, W4115088, W4115089, W4115092, W4115983, W4115984, W4115985, W4115986, W4115987, W4115989, W4115992, W4115993, W4115994, W4115996, W4115997, W4115998, W4115999, W4116000, W4117692, W4118914, W4118915, W4118916, W4118917, W4118918, W4118920, W4118921, W4118922, W4118923, W4118924, W4118925, W4119506, W4119507, W4119508, W4119509, W4119510, W4119511, W4119512, W4119516, W4121009, W4121010, W4121014, W4121015, W4121022, W4121023, W4121024, W4121025, W4123474, W4123475, W4124351, W4124352, W4124353, W4124354, W4124355, W4124358, W4124359, W4125872, W4125873, W4125875, W4125876, W4125877, W4125878, W4125880, W4125881, W4125882, W4125883, W4127525, W4127526, W4127539, W4127540, W4127541, W4127542, W4127543, W4127544, W4127545, W4127546, W4130717, W4131793, W4131802, W4131803, W4132494, W4132495, W4133749, W4133750, W4134800, W4134804, W4134805, W4135742, W4135743, W4135744, W4135745, W4136590, W4136591, W4136592, W4137115, W4137116, W4137117, W4137118, W4137119, W4137120, W4137121, W4137122, W4137939, W4137940, W4137941, W4138485, W4138486, W4138487, W4139793, W4139794, W4139795, W4139796, W4139797, W4141324, W4141877, W4141878, W4141879, W4141880, W4143473, W4143474, W4143477, W4143478, W4143481, W4143482, W4144785, W4144786, W4144787, W4144790, W4144791, W4144792, W4144793, W4144794, W4144795, W4146100, W4146101, W4146102, W4146693, W4146694, W4146695, W4146696, W4146699, W4146700, W4146701, W4147116, W4147118, W4147119, W4147122, W4147123, W4149074, W4149075, W4149076, W4149078, W4149079, W4149516, W4149650, W4149651, W4149652, W4149653, W4149654, W4149655, W4151991, W4151992, W4151993, W4151994, W4151995, W4151996, W4152952, W4153609, W4153615, W4153616, W4153619, W4153620, W4153621, W4154529, W4154530, W4154560, W4154561, W4154562, W4154563, W4155253, W4155254, W4155255, W4155256, W4155257, W4155258, W4156092, W4156093, W4156094, W4156098, and W4156099 ASDB-25-015-S with Lot #'s W4010786, W4010807, W4010808, W4010809, W4012276, W4012277, W4012278, W4012293, W4012297, W4012298, W4012299, W4012301, W4012302, W4012303, W4012304, W4012305, W4012306, W4015579, W4015580, W4018218, W4018224, W4018225, W4018226, W4019737, W4019740, W4019741, W4019745, W4020135, W4020136, W4020137, W4020754, W4020976, W4020977, W4021004, W4021005, W4021006, W4021590, W4023842, W4023846, W4024368, W4024375, W4024376, W4025306, W4025333, W4025334, W4025335, W4025336, W4025340, W4025341, W4025346, W4026865, W4026866, W4026871, W4026872, W4026873, W4026877, W4026878, W4028177, W4028178, W4028205, W4028206, W4028837, W4029396, W4029397, W4029398, W4029399, W4029400, W4029401, W4029405, W4029406, W4029407, W4029409, W4029419, W4029420, W4029421, W4029422, W4029423, W4029424, W4029992, W4029996, W4029997, W4031837, W4031838, W4031845, W4031846, W4031847, W4031848, W4031849, W4031850, W4033746, W4033747, W4033748, W4033750, W4033753, W4033754, W4035189, W4035190, W4035191, W4035192, W4035193, W4036657, W4036658, W4036660, W4036662, W4036668, W4036669, W4036670, W4036671, W4036826, W4036830, W4036831, W4036832, W4036837, W4038391, W4038392, W4038393, W4038394, W4038395, W4038396, W4038397, W4038398, W4041010, W4041011, W4041012, W4041013, W4041014, W4041015, W4041765, W4041766, W4041767, W4043627, W4043629, W4043630, W4044772, W4044773, W4045391, W4045392, W4045393, W4046004, W4046280, W4046281, W4046282, W4046283, W4047729, W4047730, W4047731, W4047732, W4049876, W4049877, W4049878, W4049886, W4049898, W4049899, W4051086, W4051771, W4051885, W4052556, W4052557, W4052559, W4054324, W4054325, W4054326, W4054327, W4056458, W4056459, W4056460, W4056461, W4058228, W4058229, W4058231, W4058232, W4058233, W4058236, W4058237, W4059453, W4059454, W4060212, W4060214, W4060216, W4060217, W4060218, W4061436, W4062018, W4062019, W4062634, W4062637, W4062639, W4062640, W4063527, W4063528, W4063530, W4067363, W4067896, W4067907, W4067912, W4069130, W4069135, W4069136, W4069137, W4069138, W4070130, W4070133, W4070713, W4070716, W4071339, W4071344, W4071345, W4071346, W4071347, W4071698, W4071699, W4071700, W4071704, W4071705, W4072883, W4072887, W4072890, W4072891, W4075172, W4075176, W4075179, W4075180, W4075184, W4076673, W4076674, W4076675, W4076676, W4076677, W4076678, W4076679, W4076680, W4076688, W4076689, W4076690, W4076691, W4077443, W4077444, W4077446, W4080720, W4085551, W4085552, W4085553, W4085555, W4085562, W4085563, W4085564, W4085565, W4085566, W4087643, W4087644, W4087645, W4087648, W4088916, W4088917, W4088918, W4088919, W4088920, W4088921, W4088922, W4088923, W4088924, W4090953, W4090957, W4090960, W4090961, W4090962, W4090963, W4090964, W4090965, W4090966, W4092761, W4092762, W4092768, W4092769, W4092770, W4092771, W4092772, W4092773, W4092774, W4095496, W4095499, W4095500, W4095501, W4096105, W4096106, W4096107, W4096108, W4096109, W4096110, W4097793, W4097794, W4097795, W4098221, W4098222, W4098235, W4099949, W4099954, W4099955, W4099956, W4099959, W4099966, W4099967, W4099968, W4099969, W4099970, W4099971, W4101154, W4101155, W4101156, W4101157, W4101158, W4101159, W4101160, W4101161, W4104062, W4104063, W4104066, W4104070, W4104071, W4104075, W4104082, W4104083, W4104084, W4105323, W4105324, W4105329, W4105339, W4105340, W4105870, W4105871, W4106536, W4106538, W4106542, W4106543, W4106544, W4106548, W4106549, W4108506, W4108507, W4108510, W4108514, W4108515, W4109252, W4109254, W4109262, W4109263, W4109264, W4111075, W4111076, W4111077, W4111078, W4111246, W4111252, W4111258, W4111260, W4111261, W4111694, W4111695, W4111696, W4111697, W4114771, W4115988, W4115990, W4115991, W4115995, W4116001, W4116002, W4116003, W4116004, W4116527, W4117693, W4119513, W4119514, W4119515, W4119517, W4119518, W4119686, W4121011, W4121016, W4121026, W4122214, W4122215, W4122216, W4123472, W4123473, W4123476, W4123477, W4124356, W4124357, W4124360, W4125874, W4125879, W4125884, W4125885, W4127547, W4127548, W4129308, W4129309, W4129310, W4129311, W4130716, W4130718, W4130719, W4131791, W4131794, W4131795, W4132491, W4132492, W4132493, W4132496, W4132497, W4132498, W4133114, W4133751, W4133752, W4134801, W4134806, W4135746, W4135751, W4135752, W4136593, W4136594, W4136595, W4137942, W4138480, W4138488, W4138489, W4138490, W4138491, W4139798, W4141323, W4141881, W4141882, W4143475, W4143476, W4143479, W4143480, W4143483, W4144788, W4144789, W4144796, W4144797, W4144798, W4144799, W4144801, W4144802, W4146103, W4147117, W4147120, W4147121, W4147124, W4149077, W4149080, W4149081, W4149656, W4149657, W4149658, W4152950, W4152951, W4152953, W4153610, W4153617, W4153618, W4153622, W4155250, W4155251, W4155252, W4155259, W4155260, W4155261, W4156091, W4156095, W4156096, W4156097, and W4156100.
Root Cause
Nonconforming Material/Component
Action Taken
The firm, Cook Medical, sent an"URGENT: MEDICAL DEVICE RECALL" letter to its customers. The letter described the product, problem and actions to be taken. The customer were instructed to do the following: 1. Review the labels of impacted product shipped to your account and quarantine any affected product that remains unused. If you are a distributor and the products have been distributed, contact your customer(s) and direct them to quarantine any affected product. 2. Immediately collect and return all unused affected products at one time to Cook Medical as soon as possible. Affected product should be returned to: Cook Medical Attn: Return Goods Department 053-R 400 Daniels Way Bloomington, IN 47404 3. Complete the attached Recall Return Response form and send to Cook Medical. This form may be sent via fax using the fax number: 812-339-7316 or scanned and emailed to FieldActionsNA@CookMedical.com. Account credit will be issued to your facility upon receipt of this form with the completed information. Should you have any questions, please contact the Customer Relations Department at Cook Medical for more information. Please use FieldActionsNA@CookMedical.com, or call us toll free 1-800-457-4500, press 4, then enter extension 15-2146. Monday through Friday, 8:00AM to 4:30PM, Eastern Time.