Hemospray Endoscopic Hemostat Recalled for Powder Adhesion Risk
Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat units (14,877 devices, US and worldwide distribution) because powder can adhere to the endoscope tip, potentially making removal difficult or impossible.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a risk-of-harm medical device malfunction (endoscope adhesion and potential entrapment) where no illnesses or injuries have been reported, fitting the rubric criterion for High severity.
Plain-English summary
Wilson-Cook Medical Inc. is recalling Hemospray Endoscopic Hemostat devices (Part Numbers HEMO-10, REF G21049 and HEMO-10-EU, REF G21346) in a Class II recall by the FDA. Approximately 14,877 units have been distributed in the United States and worldwide.
The recall was initiated because the Hemospray powder can adhere to the distal end of the endoscope during use. This adhesion may cause the endoscope to stick to tissue, making it difficult or impossible for clinicians to maneuver or remove the endoscope from the patient.
Healthcare facilities and providers using affected lot numbers should cease use and contact Wilson-Cook Medical for guidance. All unexpired lot numbers are included in this recall.
The recalled product
- Product
- Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
- Manufacturer
- Wilson-Cook Medical Inc.
- Hazard
- tissue-adhesion
- device-malfunction
- endoscope-entrapment
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 (3)
- UDI/DI : a) 00827002210493
- b) 00827002213463
- All unexpired lot numbers
Distribution
Distributed nationwide across the United States.
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