Reported Dec 7, 2016 · Terminated
FMsealer Open Shears. Model FM3001
Domain Surgical, 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: Domain Surgical, Inc. · 1370 S 2100 E · Salt Lake City, UT · 84108-2244
Is this the product you have?
- FMsealer Open Shears. Model FM3001
- Lot codes and dates
- Lots
153411160321160531160991161311161442161871162091
- Lots
- Amount recalled
- 70 units US; 175 units OUS
Where it was sold
- Nationwide
- VA
Why it was recalled
Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
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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