Recall Z-1374-2023— Coloplast Manufacturing US, LLC

Name: FDA recall Z-1374-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-01

Class II · Ongoing

Class II FDA medical device recall by Coloplast Manufacturing US, LLC, initiated 2023-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis. Reason: XXX.

Recalling firm: Coloplast Manufacturing US, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-03-01
Firm location: Minneapolis, MN, United States

Product description

Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis

Reason for recall

XXX

Data sourced from openFDA. This site is unofficial and independent of the FDA.