Reported May 20, 2020 · Ongoing
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and…
Genicon, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Genicon, Inc. · 6869 Stapoint Ct Ste 112 · Winter Park, FL · 32792-6603
Is this the product you have?
- Genicon EZee Single Use
- Specimen Retrieval Bag - Product UsageThis device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction
- Lot codes and dates
Device Model 550-000-000UDI 00877972005230Lot I8920/2020-08-29
- Amount recalled
- 1550
Where it was sold
Why it was recalled
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
This product could cause temporary or reversible health problems — stop using it.
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