FDA recall Z-0796-2020

Product

Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-02-27

Report date

2020-01-22

Termination date

2023-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0796-2020