Wilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
Wilson-Cook Medical Inc. is recalling 121,241 units of Hemospray Endoscopic Hemostat due to issues with endoscope adherence and the inability to spray powder.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect (inability to spray) rather than a direct physical injury risk, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Wilson-Cook Medical Inc. is recalling 121,241 units of the Hemospray Endoscopic Hemostat (models HEMO-7, HEMO-10, HEMO-7-EU, and HEMO-10-EU). The recall affects all lot numbers of the device, which is a hemostatic device used for endoscopic gastrointestinal procedures. The affected units were distributed nationwide in the United States and in numerous countries worldwide.
The recall was initiated due to an issue with endoscope adherence and the inability to spray powder. The firm has not reported any illnesses or injuries associated with this defect. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers and consumers should stop using the affected Hemospray devices. Wilson-Cook Medical Inc. will provide an updated Instruction for Use (IFU) to address the issue. Users should contact the manufacturer for further instructions on how to proceed with the recall and the provision of the updated documentation.
The recalled product
- Product
- Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscopic gastrointestinal use Component: No
- Manufacturer
- Wilson-Cook Medical Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot Code: RPN: IHEMO-7
- HEMO-10
- HEMO-7-EU
- HEMO-10-EU Order Number: G56572
- G21049
- G24663
- 00827002210493
- 00827002246638
Distribution
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