Wilson-Cook Recalls HEMO-10 Hemospray Endoscopic Hemostat Devices
Wilson-Cook Medical is recalling HEMO-10 Hemospray Endoscopic Hemostat devices because the handle or activation knob may crack or break, potentially causing the carbon dioxide cartridge to exit the handle.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a mechanical defect that could cause a component to project towards a user or patient, posing a risk of significant injury.
Plain-English summary
Wilson-Cook Medical Inc. is recalling 89,423 units of the HEMO-10 Hemospray Endoscopic Hemostat. The recall covers all lot numbers manufactured between January 16, 2017, and January 15, 2020, for both the HEMO-7 (Order Number G56572) and HEMO-10 (Order Number G21049) models. The devices were distributed nationwide and internationally to numerous countries across the Americas, Europe, Asia, and the Middle East.
The recall was initiated due to complaints that the handle and/or activation knob on the hemostat devices cracked or broke when the device was activated. In some cases, this failure caused the carbon dioxide cartridge to exit the handle. While most reports indicated the cartridge exited with minimal force, some complaints noted that the cartridge exited with the potential to project towards a user or a patient.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected devices and contact Wilson-Cook Medical Inc. for further instructions on return or replacement.
The recalled product
- Product
- HEMO-10 Hemospray Endoscopic Hemostat
- Manufacturer
- Wilson-Cook Medical Inc.
- Affected units
- 89,423
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Wilson-Cook Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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