FDA Enforcement
Class II
Terminated
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).
Recall: Z-0061-2021
·
Reported October 14, 2020
Enforcement
- Recall Number
- Z-0061-2021
- Event ID
- 86503
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medline Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 14, 2020
- Initiation Date
- September 14, 2020
- Classification Date
- October 7, 2020
- Termination Date
- April 9, 2021
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
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).
Reason
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Code Info
Lot 5574586, Exp 01/31/2023
Distribution
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
Quantity
60 kits