MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic… — Class II medical device recall Z-1193-2023
Ongoing recall by Unetixs Vascular, Inc., reported 2023-03-08, distributed nationwide. The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intr
| Recall number | Z-1193-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unetixs Vascular, Inc., Warwick, RI, United States |
| Recall initiated | 2023-02-10 |
| Classified | 2023-03-01 |
| Reported by FDA | 2023-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,706 units |
| NDC | 11996-0000-01 |
| Model numbers | 11996-0000-01 |
Product
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
Reason for recall
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
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-1193-2023. 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.