FDA Device recall Z-0064-2021
Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist…
- FDA Device
- Class II
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II recall of Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist… 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-0064-2021 |
| 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 #650304917, MTO Protection Station Plus with Drape - 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 5550988. Exp not identified but manufactured 11/22/2019; Second included lot with unidentified lot number and no identified exp |
|---|
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-0064-2021%22
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