Home / Recalls / Unetixs Vascular, Inc. / Z-1195-2023

Z-1195-2023 Class II Ongoing

Recalled by Unetixs Vascular, Inc. — Warwick, RI

Recall Details

Product Type
Devices
Report Date
March 8, 2023
Initiation Date
February 10, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2000 units

Product Description

MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01

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.

Distribution Pattern

Worldwide distribution - US Nationwide and Global distribution.

Code Information

All Serial Numbers

Other recalls by Unetixs Vascular, Inc.

  • Z-1196-2023 Class II — MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12 (February 10, 2023)
  • Z-1194-2023 Class II — MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model (February 10, 2023)
  • Z-1193-2023 Class II — MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Mo (February 10, 2023)