Teleflex Medical recalls Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M

Recall date

February 27, 2019

Source

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

Recall number

Z-0797-2020

FDA classification

Class III

Brand / firm

Teleflex Medical

Sold / distributed

ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada

Why it was recalled

The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M