Class 2 Device Recall novaplus, General Purpose Kit

• Date Initiated by Firm: May 11, 2021
• Create Date: June 24, 2021
• Recall Status: Terminated on May 10, 2023
• Recall Number: Z-1947-2021
• Recall Event ID: 87954
• Product Classification: Kit, surgical instrument, disposable - Product Code KDD
• Product: novaplus, General Purpose Kit, Cat. No. 56603
• Code Information: Batch Numbers: 0000275724, Exp. 02/15/2022; 0000277619, Exp. 04/15/2022
• Recalling Firm/ Manufacturer: Medical Action Industries, Inc. 306; 25 Heywood Rd; Arden NC 28704-9302
• Manufacturer Reason for Recall: There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
• FDA Determined Cause: Process control
• Action: Medical Action Industries, Inc. initiated the recall by email on 05/11/2021 Distributors were instructed to notify their customers. The firm is requesting those in possession of the recalled articles discard them.
• Quantity in Commerce: 21 cases of 20 units
• Distribution: US Nationwide distribution in the states of OH, CO, CA, IL, FL, VA, TX, MN, GA, WA, MA, MD, NY, LA, AZ, OR.
• 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.