GENICON EZEE Retrieval, sterile, Rx only.
Check against the official notice below — it lists the full affected range.
Genicon, Inc. is recalling 2,967 units of GENICON EZEE Retrieval, a sterile prescription medical device, due to a defect in which the plastic handle breaks off the shaft. This defect prevents the device from being removed according to the manufacturer's Instructions for Use. The affected products were distributed within the United States to Florida, Illinois, Michigan, Tennessee, and Utah, as well as internationally to the Dominican Republic, Ireland, Denmark, Spain, Switzerland, and the United Kingdom.
The recalled devices have catalog number 550-000-000 and lot numbers I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09, with UDI 00877972005223. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.
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. Quantity: 2,967 units Lot/code info: Catalog No. 550-000-000; Lot No. I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09; UDI: 00877972005223.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.