Z-1417-2021 Class II Terminated
FDA device recall Z-1417-2021 was initiated by Vectornate USA Inc on February 16, 2021 and is designated Class II. 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. The recall status is terminated (terminated December 8, 2022). Affected quantity: 130,000 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 21, 2021
- Initiation Date
- February 16, 2021
- Termination Date
- December 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130,000 devices
Product Description
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
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.
Distribution Pattern
US Nationwide distribution in the state of NJ.
Code Information
Serial #: STM-UNV-0001-Q121, Lot #: JAH161, KAG076