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Hemospray recallZ-0036-2025 · Wilson-Cook Medical Inc. · initiated Aug 29, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Wilson-Cook Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

The recalling firm issued letters on and dated 8/29/2024 via FedEx to U.S. customers and via email to OUS customers. The letter explained the reason for recall, risk to health, product identification and device information, and the actions to be taken by the customer. The actions included: (1) Examine inventory immediately to determine if you have affected device(s) and quarantine affected device(s). Immediately cease all use of the affected devices; (2) Return the affected device(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a credit; (3) Complete and return the Acknowledgement and Receipt Form within 5 business days of receiving the letter even if you do not have the affected devices on hand; (4) Share the notice with the appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred; and (5) Immediately report adverse events to Cook Medical Customer Relations by phone or email. The actions to be taken by the distributor include the same actions as provided for the customer except the distributor was instructed to immediately cease all distribution of the affected devices. UPDATE PER 10/25/2024 email: The recalling firm expanded their recall to include additional lot numbers as a result of receiving reports of additional complaints and adverse events. The firm issued letters on and dated 11/1/2024 via FedEx and email to only consignees who received the expanded lot numbers. The letter made reference to the original recall of 8/29/2024 and contained similar details to that letter. UPDATE PER 1/20/2025 EMAIL: The recalling firm issued letters dated 29-October-2024 on 1/10/2025 to an additional 8 OUS consignees as a result of some on-hold inventory being inadvertently distributed. Included with the letter to the 8 OUS customers was a specifically tailored short list (spreadsheet) of the lot numbers they purchased.

Recall details

Recall number
Z-0036-2025
Status
Open, Classified
Initiated by the company
Aug 29, 2024
Posted by the FDA
Oct 16, 2024
Recalling firm
Wilson-Cook Medical Inc.
Quantity
UPDATE-4,605 devices
Product code
QAU
FDA submissions
K200972
Distribution
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.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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