FDA Device recall Z-0062-2021
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits con…
- FDA Device
- Class II
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II recall of Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits con… by Medline Industries, citing non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0062-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-14 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - 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.
Identifiers
| code_info | Lot 5554524, Exp 12/31/2022; second lot with no lot recorded and no exp identified |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0062-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.