Recall Z-0061-2021— Medline Industries Inc
Class II · Terminated
Class II FDA medical device recall by Medline Industries Inc, initiated 2020-09-14, terminated 2021-04-09. FDA's recall record names no specific 510(k) clearance for this event. 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).. Reason: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities..
- Recalling firm
- Medline Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-14
- Terminated
- 2021-04-09
- Firm location
- Northfield, IL, United States
Product 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 for recall
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Data sourced from openFDA. This site is unofficial and independent of the FDA.