Reported Apr 29, 2020 · Terminated
HEMO-7 Hemospray Endoscopic Hemostat
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?
- HEMO-7 Hemospray Endoscopic Hemostat
- Lot codes and dates
- All Lot numbers manufactured 01/16/2017 - 01/15/2020
- of both the followingHEMO-7 Order Number G56572 HEMO-10 Order Number G21049
- Amount recalled
- 89,423 devices total
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
- PR
Why it was recalled
Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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