Z-0068-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 14, 2020
- Initiation Date
- September 14, 2020
- Termination Date
- April 9, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 kits
Product Description
Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).
Reason for Recall
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Distribution Pattern
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
Code Information
Lot 5619215, Exp 06/30/2023