FDAClass IIMarch 28, 2018

GENICON EZEE Retrieval recall

GENICON EZEE Retrieval, sterile, Rx only.

Why was GENICON EZEE Retrieval recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
GENICON EZEE Retrieval, sterile, Rx only.
Recalling firm
Genicon, Inc.
Quantity
2,967 units
Distribution
Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.
Recall date
March 28, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls