Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2005-2020 — 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.

U.S. FDA — Device Enforcement · United States · 2018-06-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2005-2020
Date of alert: 2018-06-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Genicon, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00877972005230

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2005-2020 — 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.

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