Device product
Kit Model #65021652, MTO Left Heart Kit United Reg Health - 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).
Z-0061-2021
Product summary
- Event
- Event 86503
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 kits
- Official record key
device-enforcement:Z-0061-2021
Official wording
Reason: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Code information: Lot 5574586, Exp 01/31/2023
Distribution pattern: US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
Derived failure modes
-
Unknown
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.