Z-3026-2018 Class II Terminated

Recalled by Vascular Technology, Inc. — Nashua, NH

Recall Details

Product Type
Devices
Report Date
September 19, 2018
Initiation Date
June 19, 2018
Termination Date
January 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 units

Product Description

VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

Reason for Recall

Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver

Distribution Pattern

US Distribution to state of: CA.

Code Information

Serial Numbers: 14329-001, 14329-002, 14329-003, 14329-004, 14329-005, 14329-006, 14329-007, 14329-008, 14329-009, and 14329-010.