medical Class II Updated 2020-05-20

Genicon, Inc. recalls Genicon EZee Single Use Specimen Retrieval Bag - Product Usa

Recalled Product

Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.


Hazard / Issue

Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29
View official government recall

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