Z-1416-2017 Class III Terminated
FDA device recall Z-1416-2017 was initiated by US Endoscopy Group Inc on December 13, 2016 and is designated Class III. 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. The recall status is terminated (terminated June 13, 2017). Affected quantity: 2,131 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2017
- Initiation Date
- December 13, 2016
- Termination Date
- June 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,131 units
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.
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.
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.