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Recall Observatory FDA recall evidence

Device product

Roth Net Polyp Retrieval

Z-1416-2017

December 13, 2016

Class III

Product summary

Firm
US Endoscopy Group Inc
Event
Event 76153
Status
Terminated
Classification
Class III
Quantity
2,131 units
Official record key
device-enforcement:Z-1416-2017

Official wording

Reason: 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.

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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.