Z-1076-2018 Class II Terminated

Recalled by Genicon, Inc. — Winter Park, FL

Recall Details

Product Type
Devices
Report Date
March 28, 2018
Initiation Date
July 19, 2017
Termination Date
May 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,967 units

Product Description

GENICON EZEE Retrieval, sterile, Rx only.

Reason for Recall

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

Distribution Pattern

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

Code Information

Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223.