Wilson-Cook Medical Inc.: Medical Device Recall in 2024 - (Recall #: Z-0036-2025)

Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.

Class II

Specific lots of product have been manufactured with nonconforming raw materials.

HEMO-7, REF G56572 - UDI-DI 00827002565722; Lot numbers: W4849600, exp. 6/27/2027; W4849968, exp. 6/28/2027; W4849969, exp. 6/28/2027; W4849970, exp. 6/28/2027; W4849971, exp. 6/28/2027; W4849972, exp. 6/28/2027; W4850219, exp. 7/1/2027; W4850220, exp. 7/1/2027; W4850221, exp. 7/1/2027; W4850659, exp. 7/2/2027; W4850660, exp. 7/2/2027; W4850662, exp. 7/2/2027; W4851084, exp. 7/3/2027; W4851085, exp. 7/3/2027; W4851086, 7/3/2027; W4852285, exp. 7/10/2027; and W4852286, exp. 7/10/2027; and HEMO-10, REF G21049 - UDI-DI 00827002210493; Lot numbers: W4849973, exp. 6/28/2027; and W4850217, exp. 7/1/2027. UPDATED 11/4/2024 FOR EXPANSION OF LOT NUMBERS: HEMO-7, REF G56572: Lot numbers: W4843115, W4843116, W4843117, W4843118, W4843119, W4849594, W4849595, W4849596, W4849597, W4849599, W4851251, W4851252, W4851253, W4851254, W4851255, W4851256, W4851257, W4851590, W4851591, W4851592, W4851596, W4851660, W4851871, W4851872, W4851874, W4851876, W4851877, W4851878, W4851879, W4851880, W4852627, W4852628, W4853096, W4853097, W4853098, W4853099, W4853100, W4853101, W4853102, W4853104, W4853105, W4853462, W4853463, W4853464, W4853465, W4853468, W4853469, W4859532, W4859533, W4859891, W4859892, W4859894, W4859895, W4859896, W4859897, W4859898, W4859899, W4860112, W4853470, W4853471, W4853948, W4853949, W4853950, W4853952, W4853954, W4854699, W4854700, W4854702, W4854703, W4854704, W4854705, W4854706, W4855265, W4855266, W4855267, W4855269, W4855270, W4855271, W4855272, W4855696, W4855697, W4855701, W4856471, W4856889, W4856892, W4856893, W4856894, W4856895, W4857327, W4857719, W4858445, W4858449, W4858450, W4858452, W4858454, W4858869, W4859152, W4859529, W4859530, W4859531, W4845546, W4845880, W4845881, W4845882, W4845883, W4845884, W4845886, W4845889, W4846299, W4846301, W4846303, W4847081, W4847085, W4847495, W4847496, W4847497, W4847498, W4847499, W4847500, W4847504, W4847892, W4847893, W4847894, W4847896, W4848132, W4848709, W4848710, W4848711, W4848712, W4848713, W4848714, W4848715, W4848716, W4848717, W4849067, W4849068, W4849070, W4849071, W4849072, W4849074, W4849075, W4849593, W4843512, W4843513, W4843514, W4843515, W4843516, W4843517, W4843518, W4843520, W4843860, W4843861, W4843862, W4843863, W4843865, W4843867, W4843868, W4843869, W4844246, W4844247, W4844248, W4844249, W4844251, W4844252, W4844253, W4844254, W4844643, W4844644, W4844646, W4844647, W4844649, W4844651, W4845120, W4845121, W4845122, W4845124, W4845125, W4845538, W4845539, W4845540, W4845541, W4845542, W4845543, and W4845545. HEMO-10, REF G21049, Lot numbers: W4843112, W4843113, W4843519, W4843864, W4843866, W4844250, W4844645, W4845117, W4845537, W4845544, W4845885, W4845888, W4847502, W4847503, W4848136, W4848708, W4849066, W4849069, W4849592, W4849598, W4851258, W4851593, W4851873, W4852282, W4853103, W4853467, W4853945, W4854701, W4855273, W4855699, W4858447, W4858868, W4859528, W4859890, W4859893, W4860295, and W4860304. UPDATE FROM 1/20/2025 EXPANSION: HEMO-7, REF G56572 - Lot numbers W4845123, W4843511, and W4845887.

Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Costa Rica, and Guatemala. UPDATE 1/30/2025: Foreign distribution was made to: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Latvia, Luxembourg, Mexico, Myanmar, Netherlands, Norway, New Zealand, Poland, Portugal, Romania, Singapore, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Voluntary: Firm initiated