FDA-Device2020-01-22Class III
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Teleflex Medical
Hazard
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.
Sold states
ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada
Affected count
13104 devices
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0797-2020Don't want to check this manually?
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