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FDAFDA · Food and drugs·Recall number Z-2275-2020

Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.

Published June 17, 2020 · Recall initiated: August 21, 2018

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

There is potential for the plastic optical tip to become detached from the metal shaft.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Genicon, Inc.
Distributor
US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
Lot
Lots I7968-A, I8182-A
Risk classification
Class II
Area (FDA)
device
Country
United States

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