Class 2 Device Recall Acusnare Polypectomy Snare

• Date Initiated by Firm: January 04, 2019
• Create Date: April 12, 2019
• Recall Status: Terminated on July 21, 2020
• Recall Number: Z-1132-2019
• Recall Event ID: 81956
• 510(K)Number: K851958
• Product Classification: Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
• Product: Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Wilson-Cook Medical Inc.; 4900 Bethania Station Rd; Winston Salem NC 27105-1203
• For Additional Information Contact: Customer Relations; 800-457-4500
• Manufacturer Reason for Recall: Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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.
• Quantity in Commerce: 34,456 units
• 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.
• 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.

• 510(K) Database: 510(K)s with Product Code = KNS