Uromedica Inc. recalls ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel…

Recall date

April 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1808-2020

FDA classification

Class II

Brand / firm

Uromedica Inc.

Sold / distributed

Nationwide distribution to the following states: CA, GA, FL, MI, and VA.

Why it was recalled

Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.