FDA-Device2018-03-28Class II
GENICON EZEE Retrieval, sterile, Rx only.
Genicon, Inc.
Hazard
Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.
Sold states
Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.
Affected count
2,967 units
Manufactured in
6869 Stapoint Ct Ste 112, N/A, Winter Park, FL, United States
Products
GENICON EZEE Retrieval, sterile, Rx only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1076-2018Don't want to check this manually?
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