Reported Jun 28, 2023 · Ongoing
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
Wilson-Cook Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wilson-Cook Medical Inc. · 4900 Bethania Station Rd · Winston Salem, NC · 27105-1203
Is this the product you have?
- Hemospray Endoscopic HemostatReference
- Part Numbers
a) HEMO-10REF G21049b) HEMO-10-EUREF G21346
- Lot codes and dates
- UDI/DI
a) 00827002210493b) 00827002213463All unexpired lot numbers
- UDI/DI
- Amount recalled
- 14,877 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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