Genicon EZee Specimen Retrieval Bag Recall for Labeling Clarity
Genicon is recalling 1,550 units of the EZee Single Use Specimen Retrieval Bag to provide updated labeling instructions for multiple specimen retrieval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding device usage instructions. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries are rated as Moderate.
Plain-English summary
Genicon, Inc. is recalling 1,550 units of the EZee Single Use Specimen Retrieval Bag (Model 550-000-000). The recall is limited to Lot I8920, manufactured on August 29, 2020. The device is a disposable, sterile bag intended for single use, though it may be used for multiple specimen retraction.
The recall is being conducted to provide users with updated Instructions for Use (IFU) labeling. The new labeling is intended to provide clarity on how to properly use the device for multiple specimen retrieval.
The affected units were distributed worldwide, including nationwide distribution in the United States and in the states of Illinois, Indiana, Missouri, and Tennessee, as well as in Denmark. Users should contact Genicon, Inc. to obtain the updated labeling instructions.
The recalled product
- 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.
- Manufacturer
- Genicon, Inc.
- Hazard
- Affected units
- 1,550
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Device Model 550-000-000
- UDI 00877972005230
- Lot I8920/2020-08-29
Distribution
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