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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Cook Inc.: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.

Agency Publication Date: December 23, 2020
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Affected Products

Product: Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13047587, 13089578, 13089579, 13126439, 13138927, 13197460, 13197462, 13203165, 13219551, 13221814, 13276233, 13312697, 13349024, 13380378, NS13094335, NS13226779

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13047588, 13050227, 13050229, 13130291, 13138925, 13203167, 13226780, 13276230, 13315165, 13332154, 13375204, 13375207

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13059453, 13059454, 13059455, 13059463, 13126438, 13197461, 13197463, 13207360, 13207367, 13234807, 13279094, 13346108, 13279103X, NS13059462, NS13260029, NS13304443, NS13312714, NS13346096, NS13352471, NS13372477, NS13410219, NS13426314

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13029693, 13029694, 13039738, 13039739, 13094338, 13094339, 13094340, 13094344, 13112923, 13112926, 13112927, 13119643, 13121403, 13124432, 13124433, 13126447, 13126448, 13126462, 13135821, 13135822, 13138934, 13138941, 13143088, 13143089, 13143090, 13145948, 13145949, 13153368, 13155283, 13158193, 13158194, 13158195, 13159695, 13163184, 13172666, 13172667, 13172668, 13189166, 13189167, 13189168, 13189171, 13194980, 13197476, 13197477, 13197478, 13197479, 13197480, 13202941, 13202942, 13202943, 13202944, 13202945, 13202946, 13202947, 13202948, 13202949, 13202950, 13202951, 13202953, 13207444, 13207445, 13207446, 13207447, 13207448, 13207449, 13207450, 13207451, 13207452, 13207453, 13207454, 13207455, 13207456, 13207457, 13207458, 13262315, 13262317, 13262321, 13265318, 13268024, 13268028, 13268030, 13268031, 13276235, 13276239, 13276242, 13279088, 13279105, 13281543, 13281544, 13288125, 13291883, 13301861, 13304456, 13318043, 13323500, 13323501, 13337799, 13337809, 13346109, 13352474, 13354244, 13357252, 13363227, 13366216, 13372480, 13391143, NS13108032

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13101181, 13121311, 13141330, 13153425, 13159709, 13170659, 13175451, 13186259, 13205335, 13205336, 13205337, 13205338, 13205339, 13205340, 13205341, 13214445, 13217109, 13217110, 13219549, 13226821, 13226822, 13226823, 13226824, 13226825, 13262316, 13262318, 13262383, 13262384, 13262385, 13262386, 13262387, 13262388, 13265309, 13265310, 13265311, 13265312, 13265313, 13265314, 13265315, 13265316, 13265317, 13265319, 13265321, 13268016, 13268018, 13268019, 13268020, 13268021, 13268022, 13268023, 13268025, 13268026, 13268027, 13268029, 13276232, 13276234, 13276236, 13276243, 13279089, 13315183, 13346074, 13346097, 13391157, NS13108062

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13089576, 13105053, 13130281, 13130282, 13135871, 13159711, 13159712, 13162740, 13166130, 13170660, 13175442, 13175443, 13186252, 13189278, 13192082, 13192083, 13192085, 13192086, 13192087, 13194970, 13194971, 13194973, 13194974, 13200438, 13203161, 13203162, 13203164, 13205342, 13205343, 13207358, 13207359, 13207361, 13207362, 13207363, 13207364, 13207365, 13207366, 13217123, 13219553, 13219554, 13223827, 13223828, 13226776, 13240001, 13243202, 13262322, 13276244, 13279106, 13304457, 13310767, 13315203, 13323502, 13329236, 13332175, 13337810, 13352475, 13360432, 13291884X, NS13077815, NS13077819, NS13105057, NS13105059, NS13192090, NS13226781, NS13315204, NS13376992

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13077814, 13089577, 13105054, 13140910, 13159710, 13162739, 13170661, 13186251, 13192084, 13194969, 13194972, 13200439, 13203160, 13203163, 13203166, 13214447, 13214449, 13217121, 13217122, 13219552, 13223826, 13223829, 13237651, 13276238, 13276245, 13286649, 13357239, 13366218, 13391145, NS13089580, NS13105058, NS13130292, NS13138931, NS13192091, NS13234809, NS13252367, NS13252368, NS13286655, NS13349016, NS13352450, NS13366219, NS13372482, NS13375232, NS13401834, NS13420125

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13189185, 13194984, 13202958, 13205307, 13207466, 13207473, 13231809, 13234793, 13249454, 13262331, 13268033, 13288117, 13303369, 13303376, 13315174, 13332151, 13337783, 13337797, 13346088, 13346089, 13357215, 13357232, 13360414, 13366236, 13377003, 13401855, NS13357214, NS13366235

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13135825, 13138939, 13138940, 13143095, 13143096, 13143097, 13150435, 13150438, 13150439, 13150440, 13150441, 13153382, 13153386, 13153387, 13155287, 13155288, 13155295, 13155296, 13158205, 13159698, 13159699, 13159701, 13159702, 13159703, 13159704, 13159705, 13166156, 13166160, 13166161, 13166162, 13172674, 13172679, 13172680, 13172681, 13175467, 13175468, 13175472, 13180819, 13186324, 13186325, 13186326, 13186329, 13186331, 13189188, 13189189, 13189190, 13189195, 13189196, 13189197, 13192073, 13197482, 13200417, 13200418, 13202955, 13202956, 13205308, 13207461, 13207462, 13207463, 13207464, 13211828, 13214464, 13214465, 13217129, 13217132, 13217133, 13217134, 13217135, 13217136, 13217137, 13221800, 13221806, 13221807, 13226796, 13226797, 13226798, 13226799, 13226800, 13226801, 13231821, 13237671, 13237672, 13240020, 13240021, 13240022, 13240023, 13240024, 13240025, 13246564, 13246565, 13256701, 13256707, 13256708, 13256709, 13256710, 13256711, 13262346, 13262347, 13268037, 13281553, 13281792, 13281793, 13281794, 13281795, 13281796, 13281797, 13281798, 13281799, 13291872, 13291875, 13294539, 13294540, 13294541, 13294542, 13297253, 13297254, 13297255, 13297256, 13297257, 13301868, 13301869, 13301870, 13304446, 13307201, 13307202, 13307203, 13307204, 13310756, 13310757, 13310758, 13312696, 13312701, 13312702, 13312703, 13315213, 13315214, 13315215, 13315216, 13318057, 13318058, 13320584, 13320592, 13320593, 13329231, 13329243, 13329244, 13329245, 13329247, 13332165, 13332166, 13334765, 13334766, 13334772, 13342864, 13342865, 13342866, 13346103, 13346104, 13346117, 13349025, 13349035, 13349036, 13352476, 13352477, 13352478, 13352479, 13352480, 13352481, 13352482, 13352483, 13357255, 13357256, 13360433, 13360434, 13360435, 13360436, 13360437, 13360439, 13366224, 13366225, 13372603, 13372604, 13375216, 13375217, 13375218, 13375219, 13375220, 13376996, 13380383, 13382713, 13382714, 13382715, 13382716, 13388322, 13388323, 13388324, 13391160, 13398852, 13423953, 13432833, 13446739, 13446740, 13455461, 13334771X

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13135824, 13140931, 13141304, 13141305, 13145950, 13145951, 13150436, 13150442, 13150443, 13153380, 13153383, 13153384, 13153385, 13155286, 13155289, 13155291, 13158203, 13158204, 13158208, 13162736, 13162737, 13163193, 13166157, 13166158, 13166159, 13172675, 13172676, 13172677, 13172678, 13175465, 13175466, 13175469, 13175470, 13175471, 13180815, 13180818, 13186322, 13186327, 13186328, 13189186, 13189191, 13189192, 13189193, 13189194, 13189198, 13189199, 13197483, 13200412, 13200413, 13200414, 13202954, 13205305, 13205306, 13207459, 13211825, 13211829, 13214442, 13214443, 13214444, 13217124, 13219557, 13219561, 13219562, 13219563, 13219564, 13221801, 13221808, 13221809, 13226802, 13226803, 13226804, 13229671, 13229678, 13229679, 13231822, 13234798, 13243204, 13243215, 13243216, 13243217, 13243218, 13243219, 13252359, 13260007, 13260018, 13262325, 13262326, 13265328, 13279083, 13279084, 13281529, 13281779, 13281780, 13281781, 13281782, 13288114, 13291865, 13294510, 13297239, 13301844, 13301845, 13301846, 13307175, 13307176, 13307177, 13310722, 13310723, 13310730, 13310731, 13312686, 13315170, 13315171, 13315172, 13318023, 13318033, 13318034, 13318035, 13332157, 13332158, 13334762, 13337772, 13337776, 13337777, 13337778, 13337779, 13337794, 13337795, 13342831, 13342837, 13342838, 13342839, 13342857, 13342858, 13342859, 13346085, 13348996, 13348997, 13348998, 13348999, 13349000, 13349001, 13352433, 13352440, 13352468, 13354239, 13354247, 13354248, 13354249, 13354250, 13354251, 13357224, 13357225, 13360405, 13360406, 13363206, 13363207, 13363215, 13363216, 13363217, 13369413, 13369414, 13369422, 13369423, 13372605, 13375223, 13375224, 13375225, 13376997, 13380390, 13380391, 13382717, 13384997, 13384998, 13391147, 13391148, 13391149, 13396148, 13398853, 13398854, 13398855, 13401842, 13407495, 13432838, 13375222X

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13143098, 13143099, 13143100, 13145952, 13145953, 13145955, 13150444, 13150446, 13159696, 13159697, 13159706, 13159708, 13166164, 13166165, 13166168, 13175473, 13175474, 13175480, 13178582, 13186336, 13192068, 13192074, 13211826, 13211827, 13214440, 13217125, 13217126, 13221802, 13223830, 13223831, 13229680, 13231823, 13231824, 13240026, 13240027, 13243203, 13246547, 13246566, 13252353, 13260022, 13260023, 13265330, 13265331, 13265335, 13268038, 13279080, 13281540, 13281800, 13281801, 13286656, 13286658, 13286659, 13286660, 13286662, 13288115, 13304447, 13306333, 13306334, 13307178, 13307189, 13315200, 13315217, 13320585, 13320594, 13329232, 13329248, 13332167, 13334774, 13334775, 13342868, 13349026, 13352485, 13366188, 13366191, 13366194, 13366195, 13366196, 13369415, 13369426, 13380379, 13382712, 13391138, 13391139, 13396128, 13404831, 13404832, 13416497, 13420104, 13420105, 13281802X, NS13315219, NS13315220, NS13329249, NS13334773, NS13349037, NS13352484, NS13352486, NS13401845, NS13426336

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13143101, 13150445, 13159707, 13159715, 13166166, 13168195, 13186332, 13186337, 13214441, 13217127, 13221797, 13223835, 13229666, 13237660, 13246546, 13249446, 13262327, 13265329, 13291866, 13294513, 13307179, 13318024, 13332149, 13332159, 13337780, 13337796, 13346086, 13352434, 13352441, 13354252, 13366190, 13366197, 13382711, 13396125, 13398833, 13398835, 13413758, 13420106

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13205314, 13205322, 13229673, 13229685, 13234800, 13249450, 13256702, 13262338, 13265332, 13265337, 13279097, 13288121, 13291877, 13297249, 13297260, 13297261, 13301872, 13310761, 13312706, 13318040, 13318062, 13332170, 13346105, 13349029, 13354271, 13354272, 13357259, 13360427, 13360442, 13366230, 13372465, 13372469, 13375211, 13375227, 13377002, 13391151, 13398856, 13426338, 13329254X, 13332169X, 13342871X

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13192055, 13192067, 13200423, 13200424, 13202961, 13202963, 13205309, 13205315, 13205323, 13205324, 13223833, 13229686, 13229687, 13231803, 13234792, 13234801, 13237654, 13243208, 13243209, 13246544, 13246548, 13249451, 13249452, 13249453, 13254617, 13254618, 13262329, 13262330, 13279085, 13281530, 13281531, 13281790, 13281791, 13286645, 13286646, 13286647, 13286648, 13286650, 13286651, 13286652, 13303358, 13303361, 13303362, 13303366, 13303367, 13303368, 13303371, 13303372, 13303373, 13303374, 13303375, 13306335, 13306336, 13319484, 13319489, 13319495, 13346087, 13349006, 13352444, 13354260, 13354261, 13354262, 13357229, 13357230, 13360411, 13360412, 13360413, 13363220, 13363221, 13366231, 13366232, 13372470, 13372491, 13380384, 13382718, 13388328, 13391161, 13398857, 13401849, 13435154, 13438159, 13449366, 13449367, 13455464, 13279081X

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13197465, 13203168, 13203169, 13205344, 13205348, 13229675, 13229688, 13265333, 13268039, 13281806, 13310762, 13318041, 13329229, 13329233, 13342873, 13349039, 13354264, 13357260, 13372472, 13398839, 13441228, NS13186257, NS13186258, NS13246550, NS13260027, NS13304448, NS13329255, NS13329256, NS13333102, NS13354273, NS13354274, NS13360443, NS13360444, NS13388330, NS13401851

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13135874, 13141336, 13162743, 13168158, 13192089, 13214454, 13229690, 13237656, 13265339, 13297262, 13312708, 13320587, 13323491, 13342872, 13349041, 13363230, 13382710, 13407498, NS13140914, NS13219558, NS13221811, NS13246568, NS13265338, NS13291878, NS13291879, NS13312707, NS13342874, NS13349040, NS13360428, NS13372495

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13105055, 13124400, 13124401, 13135880, 13138926, 13140911, 13141335, 13162741, 13162742, 13168155, 13168156, 13170665, 13189283, 13214450, 13214451, 13214452, 13214455, 13221812, 13231810, 13237657, 13249434, 13252354, 13252362, 13262332, 13288118, 13291868, 13294511, 13307182, 13315176, 13337784, 13337785, 13337786, 13346090, 13354241, 13357216, 13360416, 13366208, 13366240, 13380385, 13388332

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13297248, 13318063, 13320595, 13334764, 13388304, 13435140, 13291880X, NS13246556, NS13265340, NS13288123

Lot Numbers:
Numbers
Product: Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13229667, 13231805, 13254613, 13291858, 13291869, 13310725, 13318020, 13337787, 13337798, 13346070, 13354237, 13366209, 13369431, 13375208, 13391162, 13407499, 13435157, NS13401856,

Lot Numbers:
Numbers
Product: Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 13029776, 13050652, 13082600, 13082601, 13082603, 13101307, 13101310, 13131722, 13141048, 13141049, 13150557, 13155318, 13155322, 13179880, 13186371, 13186372, 13192133, 13211850, 13237759, 13274344

Lot Numbers:
Numbers
Product: Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Lot Numbers: 10332622, 10332623, 10335453, 10335456, 10338048, 10338049, 10338050, 10342579, 10342580, 10342581, 10342582, 10342590, 13002891, 13002897, 13006165, 13006166, 13006181, 13008773, 13008784, 13008785, 13008786, 13008787, 13011537, 13011538, 13014541, 13014545, 13020497, 13020498, 13020511, 13023868, 13023878, 13023879, 13029745, 13029746, 13029747, 13029748, 13029749, 13029750, 13029751, 13035275, 13039774, 13043788, 13043802, 13043803, 13043804, 13043805, 13043806, 13043807, 13047789, 13047790, 13050311, 13050324, 13050325, 13086346, 13086347, 13086348, 13089656, 13089657, 13094405, 13097678, 13097679, 13097681, 13097691, 13097692, 13101233, 13105097, 13105098, 13105099, 13105100, 13105101, 13126489, 13126490, 13126491, 13128737, 13128738, 13134895, 13134897, 13141007, 13141008, 13141009, 13141010, 13143117, 13143120, 13143121, 13143129, 13143130, 13143131, 13178615, 13178617, 13186365, 13186366, 13189358, 13192148, 13192149, 13195043, 13197524, 13197525, 13197526, 13197533, 13200500, 13205399, 13205415, 13205416, 13205417, 13205418, 13207558, 13207586, 13219603, 13221896, 13221903, 13223326, 13223327, 13223328, 13223329, 13223330, 13223331, 13223332, 13223333, 13226894, 13229771, 13229772, 13231878, 13231879, 13234846, 13234847, 13237736, 13240039, 13240048, 13240066, 13246623, 13246624, 13246625, 13249506, 13249507, 13249508, 13254754, 13260085, 13268159, 13274346, 13274363, 13274364, 13274365, 13276219, 13276220, 13276221, 13276222, 13279330, 13281720, 13281732, 13281733, 13284579, 13284580, 13284581, 13284582, 13284583, 13288184, 13288185, 13292062, 13294665, 13312741, 13312742, 13312750, 13315287, 13315288, 13315289, 13318101, 13318109, 13320658, 13320659, 13320660, 13320661, 13323519, 13323520, 13323521, 13323546, 13327092, 13327093, 13329060, 13329061, 13332072, 13332073, 13346140, 13346160, 13346161, 13346162, 13349095, 13349100, 13349125, 13352236, 13352237, 13352238, 13352239, 13352240, 13354220, 13363114, 13363115, 13363140, 13363141, 13363142, 13410269, 13458470, 13458471 Additional lot as of 1/14/21 - 13312743

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86804
Status: Resolved
Manufacturer: Cook Inc.
Manufactured In: United States
Units Affected: 21 products (611; 383; 458; 4767; 2605; 2807; 1262; 9768; 8362; 4408; 1780; 1967; 3797; 1024; 1152; 228; 1527; 228; 631; 902; 9310 (2 additional as of 1/14/21))
Agency Last Updated: September 7, 2022

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.