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Roth Net Polyp Retrieval

FDA Recall #Z-1416-2017 — Class III — December 13, 2016

Recall #Z-1416-2017 Date: December 13, 2016 Classification: Class III Status: Terminated

Product Description

Roth Net Polyp Retrieval

Reason for Recall

The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.

Recalling Firm

US Endoscopy Group Inc — Mentor, OH

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product Quantity

2,131 units

Distribution

US Distribution to the states of : AL, CA, CO, IL, KS, MA, MT, NC , NE , NY, OH, PA, TN, TX and WA. Product was also shipped to the following countries: Australia, Belgium, Canada, Czech Republic, Ireland, Kuwait, Norway, Poland & Sweden.

Code Information

Model # 0071151; Lot #s: 1613898, Exp. Date October 5, 2019; Lot # 1616337, Exp. Date October 7, 2019; Lot # 1616733, Exp. Date October 7, 2019; Lot # 1616734, Exp. Date October 20, 2019 & Lot # 1616735, Exp. Date October 28, 2019.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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