Stop using now Medical device recall · FDA · Published November 24, 2020
Cook Flexor Check-Flo Introducer Recall: Risk of Sheath Separation During Use
Cook recalls Flexor Check-Flo Introducers with specific lot numbers due to risk of sheath separation during use, which could cause life-threatening events like hemorrhage or vessel injury.
Stop using this now
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.
Contact the company
Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
What happened, in plain English
Cook is recalling certain Flexor Check-Flo Introducers that may separate during use, potentially causing life-threatening events such as hemorrhage or vessel injury. Affected units have specific lot numbers listed in the recall. Read more at govinfonow.com/recall/63778-cook-flexor-check-flo-introducer-recall-risk-of-sheath-separation.
Source Summary by GovInfoNow · govinfonow.com/recall/63778-cook-flexor-check-flo-introducer-recall-risk-of-sheath-separation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0598-2021
Cite this page
“Cook Flexor Check-Flo Introducer Recall: Risk of Sheath Separation During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63778-cook-flexor-check-flo-introducer-recall-risk-of-sheath-separation. Based on FDA recall #Z-0598-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0598-2021%22&limit=1).
Why it’s dangerous
The introducer sheath can separate at the proximal bond site during use. If separation occurs, it may lead to life-threatening events including vessel injury, hemorrhage, or embolization that blocks blood flow to vital organs.
Who’s affected
Medical professionals using the Flexor Check-Flo Introducer for vascular procedures are most at risk, particularly those with the listed lot numbers.
How to tell if you have this one
Check the lot numbers on the device: 13135825, 13138939, 13138940, 13143095, and other specific numbers listed in the recall notice. The product is a Flexor Check-Flo Introducer with model RPN KCFW-6.0-35-55-RB-HFANL0-HC.
- Brand
Cook- Category
Medical device
All 21 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
US Nationwide Distribution including states of: AK, CT, IA, LA, MO, NH, OK, TN, WI, AL, DC, ID, MA, MS, NJ, OR, TX, WV, AR, DE, IL, MD, MT, NM, PA, UT, WY, AZ, FL, IN, ME, NC, NV, RI, VA, CA, GA, KS, MI, ND, NY, SC, VT, CO, HI, KY, MN, NE, OH, SD, WA and Global Distribution to: AU, SG, Austria, Belgium, Canary Islands, CN, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, KR, Latvia, Lithuania, MY, Morocco, Netherlands, Norway, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, TW, TH, and United Arabs Emirates.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0591-2021 | 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 | 611 |
| Z-0592-2021 | 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 | 383 |
| Z-0593-2021 | 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 | 458 |
| Z-0594-2021 | 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 | 4767 |
| Z-0595-2021 | 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 | 2605 |
| Z-0596-2021 | 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 | 2807 |
| Z-0597-2021 | 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 | 1262 |
| Z-0598-2021 | 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 | 9768 |
| Z-0599-2021 | 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 | 8362 |
| Z-0600-2021 | 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 | 4408 |
| Z-0601-2021 | 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 | 1780 |
| Z-0602-2021 | 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 | 1967 |
| Z-0603-2021 | 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 | 3797 |
| Z-0604-2021 | 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 | 1024 |
| Z-0605-2021 | 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 | 1152 |
| Z-0606-2021 | 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 | 228 |
| Z-0607-2021 | 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 | 1527 |
| Z-0608-2021 | 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 | 228 |
| Z-0609-2021 | 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, | 631 |
| Z-0610-2021 | 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 | 902 |
| Z-0611-2021 | 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 | 9310 (2 additional as of 1/14/21) |
What to do — step by step
Stop Using Immediately
Discontinue use of the Flexor Check-Flo Introducer if it has the listed lot numbers as it poses a risk of life-threatening separation.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
FDA distribution: “US Nationwide Distribution including states of: AK, CT, IA, LA, MO, NH, OK, TN, WI, AL, DC, ID, MA, MS, NJ, OR, TX, WV, AR, DE, IL, MD, MT, NM, PA, UT, WY, AZ, FL, IN, ME, NC, NV, RI, VA, CA, GA, KS, MI, ND, NY, SC, VT, CO, HI, KY, MN, NE,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0598-2021 (November 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0598-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.