Genicon EZee Single Use Specimen Retrieval Bag recall: Labeling Error
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag…
Why was Genicon EZee Single Use Specimen Retrieval Bag recalled?
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29
- 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…
- Recalling firm
- Genicon, Inc.
- Quantity
- 1550
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.
- Recall date
- May 20, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)