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Teleflex Medical recalls Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
Recalled January 22, 2020 · FDA recall Z-0796-2020 · 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. · FDA Class III
Units
39456 devices
Sold at
ME,NC, WA, MO, NJ, FL, CAL, TX, OH, IL, MA, GA, FL, GA, Canada
Description
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.
Product
Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →