FDA Device recall Z-0061-2021
Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of…
- FDA Device
- Class II
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II recall of Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of… 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-0061-2021 |
| 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 #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.
Identifiers
| code_info | Lot 5574586, Exp 01/31/2023 |
|---|
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-0061-2021%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.