FDA recall Z-1076-2018

Product

GENICON EZEE Retrieval, sterile, Rx only.

Reason for recall

Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.

Distribution

Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.

Key facts

Status

Terminated

Initiation date

2017-07-19

Report date

2018-03-28

Termination date

2020-05-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Winter Park, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1076-2018