FDA recall Z-0025-2018

Product

VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip

Reason for recall

The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.

Distribution

US nationwide distribution.

Key facts

Status

Terminated

Initiation date

2017-07-27

Report date

2017-10-25

Termination date

2019-08-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louisville, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0025-2018