Class 2 Device Recall MedSchenker Smart Transport Medium (STM) System

• Date Initiated by Firm: February 16, 2021
• Create Date: April 13, 2021
• Recall Status: Terminated on December 08, 2022
• Recall Number: Z-1417-2021
• Recall Event ID: 87575
• Product Classification: Culture media, non-selective and non-differential - Product Code JSG
• Product: MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I
• Code Information: Serial #: STM-UNV-0001-Q121, Lot #: JAH161, KAG076
• Recalling Firm/ Manufacturer: Vectornate USA Inc; 10 Industrial Ave Ste 4; Mahwah NJ 07430-2284
• For Additional Information Contact: Shreya Patil; 201-393-2973
• Manufacturer Reason for Recall: Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.
• FDA Determined Cause: Process control
• Action: The firm did not give out a public statement of a recall or recall strategy as it only affected one client and was specific to two identified lots. the firm did notify the customer of the issue via phone and email.
• Quantity in Commerce: 130,000 devices
• Distribution: US Nationwide distribution in the state of NJ.
• 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.