Class 2 Device Recall Customized kits

• Date Initiated by Firm: April 13, 2020
• Create Date: May 29, 2020
• Recall Status: Terminated on November 25, 2020
• Recall Number: Z-2173-2020
• Recall Event ID: 85502
• Product Classification: Ear, nose, and throat surgical tray - Product Code OGR
• Product: Sterile Custom Packs to be used in surgical procedures.
• Code Information: ACS Tray Numbers: AGTA481; Lot # 998201, Exp. Date 01/02/2021 (60 kits) WXEN11G; Lot # 994201, Exp. Date 01/06/2021 (32 kits) VSMT20G; Lot # 677191, Exp. Date 11/19/2020 (12 kits) AGHN20J; Lot # 636191, Exp. Date 12/30/2020 (4 kits); Lot # 675191, Exp. Date 11/21/2020 (12 kits) and Lot # 741191, Exp. Date 09/16/2020 (36 kits) AGEN11H; Lot # 657191, Exp. Date 12/09/2020 (66 kits) VSEN11F; Lot # 664191, Exp. Date 12/02/2020 (8 kits)
• Recalling Firm/ Manufacturer: American Contract Systems; Jackson Pointe Commerce; 4050 Jacksons Pointe Ct; Zelienople PA 16063-2838
• For Additional Information Contact: Steve Theissen; 952-926-3515
• Manufacturer Reason for Recall: The surgical gowns were manufactured in a facility that is not registered by the FDA.
• FDA Determined Cause: Process control
• Action: Notification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal.
• Quantity in Commerce: 2868 total kits
• Distribution: US Nationwide distribution including in the state of Pennsylvania.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.