Kit Model #65021652 — Class II medical device recall Z-0061-2021
Terminated recall by Medline Industries Inc, reported 2020-10-14, distributed nationwide. Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabiliti
| Recall number | Z-0061-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2020-09-14 |
| Classified | 2020-10-07 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2021-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 60 kits |
| Reason classes | sterility |
| Lot numbers | 5574586 |
| Model numbers | 65021652 |
| Expiration dates | 2023-01-31 |
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 for recall
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0061-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.